input stringlengths 207 4.65k | output stringlengths 61 8.46k |
|---|---|
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, PART OF THE TIP OF THE MEGA SUTURECUT NEEDLE DRIVER BROKE OFF INSIDE THE PATIEN... | A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED AND INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED TO HAVE THE MEGA SUTURECUT NEEDLE DRIVER BE RETURNED FOR EVALUATION; HOWEVER, THE INSTRUMENT HAS NOT YET BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS... |
Brand Name:ENDOWRISTDevice Problem: Material FrayedPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE FRAYED CABLE. THE WAS NO REPORT OF PATIENT INVOLVEMENT. FOLLOW-UP WAS PERFORMED TO ... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. THE FAILURE ANALYSIS (FA) CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE FENESTRATED BIPOLAR FORCEPS (FBF) WAS ANALYZED AND FOUND TO HAVE DAMAGE TO THE CONDUCTOR WIRE¿S INSULATIO... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TONGUE BASE RESECTION SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA INSTRUMENT HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH N... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS ANALYZED AND THE CUSTOMER RE... |
Brand Name:ENDOWRISTDevice Problem: Material Integrity ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS WAS OBSERVED TO HAVE A BROKEN TIP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, IN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN TIP, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS WAS ANALYZED AND FOUND TO HAVE DAMAGE TO TH... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LUNG PROCEDURE, THE SUREFORM STAPLER RELOAD DID NOT FORM A COMPLETE STAPLE LINE. A BACKUP INSTRUMENT OF SAME KIND AND A DIFFERENT RELOAD W... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PRODUCT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS (FA) FOUND THE PRIMARY FAILURE OF EXPOSED BLADE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. FOR CLARIFICATION, THE RELOAD WAS FOUND TO HAVE THE KNIFE EXPOSED WITHIN THE KNIFE TRACK. THE ... |
Brand Name:SUREFORMDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON FIRED THE STAPLER SUREFORM 60 WITH A BLUE 60 RELOAD AND THE STAPLER JAW WOULD NOT OPEN. THE CUSTOMER H... | IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON FIRED THE STAPLER WITH A BLUE 60 RELOAD AND THE STAPLER JAW WOULD NOT OPEN. THE CUSTOMER HAD TO CALL TECHNICAL SUPPORT AND HIT THE RED EMERGENCY BUTTON AND TWISTED THE KNOB ON THE STAPLER TO RELEASE THE JAW. BASED ON THE CLAIM AGAINST THE P... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING DA VINCI ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SITE EXPERIENCED A RECOVERABLE FAULT 25521 AND THE ROBOT WAS ONLY PRESENTING THE OPTION... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING RECOVERABLE FAULT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACE... |
Brand Name:DAVINCI SIDevice Problem: No Device OutputPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THE DISK ON ARM 1 WAS NOT SPINNING WHEN REGISTERING A STERILE ADAPTER. PRIOR TO CALLING, THE CUSTOMER STAT... | ISI RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PATIENT SIDE MANIPULATOR (PSM) WAS ANALYZED FAILURE ANALYSIS INVESTIGATION WAS ABLE TO CONFIRM THE REPORTED COMPLAINT UPON VISUAL INSPECTION OF THE RETURNED PRODUCT. Manufacturer Narrative: AN INTUITIVE SURGICAL, INC. (ISI) FI... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD SPARKS EMITTED DURING USE. THE CUSTOMER USED... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO THE PRIMARY FAILURE OF THERMAL DAMAGE TO THE BIPOLAR YAW PULLEY BETWEEN THE GRIPS, TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HA... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE BLEEDING. THE ION SYSTEM WAS USED TO ACCESS A FUSED BRONCHUS INTERMEDIUS DUE T... | BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. PER THE PHYSICIAN, THE VESSEL INJURY OCCURRED AFTER ALL ION PRODUCTS WERE REMOVED AND WHILE ELECTROCAUTERY WAS BEING PERFORMED WITH AN UNSPECIFIED 3RD-PARTY DEVICE. THERE IS NO ALLEGATION THAT A MALFUNCTION OF ... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WERE REPEATED RECOVERABLE ERRORS 32101 ON ARMNET 3. WHEN RECOVERED, THE FAULT CAME BACK AGAIN IMMEDIATE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED RECOVERABLE ERRORS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE CONFI... |
Brand Name:DAVINCI XIDevice Problem: Physical Resistance/StickingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TH... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING RESISTANCE WHEN MOVING THE LEFT MTM, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. T... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE ERBE ENCOUNTERED A U-02 ERROR. THE TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER DISCONNECT THE P... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A REPEATED U-02 ERROR, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPRODU... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL COLECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD AN ERROR 23138 AND THE CUSTOMER COULD NOT RECOVER IT, SO THE CUSTOMER UNDOCKED... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE ERROR 23138, AN INVESTIGATION WAS COMPLETED DETERMINE THE ROOT CAUSE. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPRODUCED THE REPORTED ISSUE ... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, A REOCCURRING ERROR REPORTED BY THE ERBE VIO (VIDEO IO) WAS DISPLA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR MESSAGES WERE DISPLAYED ON THE VIO INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU), AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUS... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER FOUND THE TENACULUM FORCEPS INSTRUMENT HAD A BROKEN WIRE WHILE USING THE ... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE TENACULUM FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF A BROKEN CABLE. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN PITCH CABLE TO BE RE... |
Brand Name:DAVINCI XIDevice Problem: Difficult to RemovePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, ONE ARM ON THE PATIENT SIDE CART (PSC) STOPPED WORKING. AS A RESULT, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT THAT WAS I... | NO ISI DEVICE RELATED TO THIS EVENT HAS BEEN RETURNED FOR ANALYSIS. AS A RESULT, THE ROOT CAUSE OF THE REPORTED ISSUE HAS NOT BEEN IDENTIFIED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. ON (B)(6) 2022, TWO PROCEDURES WERE PERFORMED ON SYSTEM (B)(4). DURING ONE PROCEDURE, UNIVERSAL... |
Brand Name:NONEDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE CUSTOMER WAS UNABLE TO TEST THE HARMONIC ACE INSTRUMENT AFTER A ¿BLADE INPUT MITIGATION¿ ... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN BLADE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. TH... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSVERSE COLECTOMY SURGICAL PROCEDURE, A SYSTEM WAS HAVING A NON-RECOVERABLE FAULT. THE CUSTOMER CALLED INTO TECHNICAL SUPPORT ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A NON-RECOVERABLE FAULT WAS RECEIVED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. ... |
Brand Name:ENDOWRISTDevice Problem: Material Fragmentation; No Apparent Adverse EventPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY - SIMPLE SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK WAS BROKEN. THERE WAS NO REPORT OF FRAGM... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED, THE PERMANENT CAUTERY HOOK INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE PERMANENT CAUTERY HOOK WAS ANALYZED AND FOUND TO HAVE AN EAR OF THE DISTAL CLEVIS BROKEN. THE BROKEN P... |
Brand Name:SUREFORMDevice Problem: Failure to CutPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, A SUREFORM 60 STAPLER INSTRUMENT FIRED A RELOAD AND THE TARGET TISSUE WAS PUSHED AND BUNCHED. THERE WAS NO REPORTED PATIENT INJURY. T... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION HAS BEEN DEEMED TO BE PRODUCT RELATED. ISI HAS RECEIVED THE SUREFORM 60 STAPLER INSTRUMENT AND A GREEN SUREFORM 60 RELOAD THAT WAS RECEIVED IN ITS JAWS. UPON VISUAL INSPECTION OF THE STAPLER RELOAD, ALL PUSHERS WERE FOUND AT THE BED SURFACE OF TH... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Air Embolism; Stroke/CVA; Convulsion/SeizureEvent Description: IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A POST PROCEDURE STROKE, SEIZURE, NEUROLEPTIC MALIGNANT SYNDROM... | BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATIONS CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. AS OF 08-DEC-2022, A REVIEW OF THE SITE'S... |
Brand Name:DA VINCI ENERGYDevice Problem: No Device Output; Detachment of Device or Device Component; Device Dislodged or DislocatedPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED T... | INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS VISUALLY INSPECTED PRIOR TO USE WITH NO ISSUE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THERE WAS NO FRAGMENT THAT FELL INS... |
Brand Name:ENDOWRISTDevice Problem: Failure to Deliver EnergyPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL SMALL BOWEL RESECTION GASTRECTOMY SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND INSTRUMENT FAILED TO SEAL. THE PROCEDURE WAS COMP... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING VESSEL SEALER EXTEND INSTRUMENT WOULD NOT SEAL, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. FA WAS NOT ABLE TO CONFIRM/REPRODUCE THE ... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT ARM ANGLE ALLEGEDLY CHANGED DURING CLIP APPLICATION... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER REGARDING CLIP APPLICATION FAILURE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ALTHOUGH THE COMPLAINT REGARDING THE ISSUE WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE INSTRUMENT WAS NOT RETURNED, THE INFORMATION GATHERED INDICA... |
Brand Name:DA VINCI SPDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Ecchymosis; Hemoptysis; Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED RIGHT MIDDLE LOBE PULMONARY LOBECTOMY PROCEDURE, THE PATIENT, WHO WAS PART OF A COMPLETED PILOT STUDY ... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S POST-OPERATIVE COMPLICATION WAS DUE TO "MAL-RESECTION," ACCORDING TO THE INITIAL REPORTER, USING A 3RD-PARTY STAPLER AND UNUSUAL ANATOMY OF THE PATIENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT/INCI... |
Brand Name:DA VINCIDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO START OF A DA VINCI-ASSISTED NISSEN FUNDOPLICATION SURGICAL PROCEDURE, THE SYSTEM EXHIBITED THE MESSAGE "ENDOSCOPE SELF-TEST FAILED". THERE WAS NO REPORT ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SELF-TEST FAILED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE FAILED THE CHECK ENDOSCOPE... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE MEDIUM-LARGE CLIP APPLIER (MLCA) INSTRUMENT WAS DIFFICULT TO BE INSER... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE MOTION OF THE MEDIUM-LARGE CLIP APPLIER (MLCA) INSTRUMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. ALTHOUGH THE... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA IPOM SURGICAL PROCEDURE, THE OPERATION ROOM (OR) NURSE CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPOR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE OCCURRENCE OF ERROR C-34 ON ERBE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THE REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAIN... |
Brand Name:DAVINCI SIDevice Problem: No Display/ImagePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD ILLUMINATOR ERROR FOR LAMP MODULE, THE SYSTEM POPS UP ERROR 48245 WHILE TURNING ON THE ILLUMI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ILLUMINATOR FAILED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE CHECKED AND RESEATED THE LAMP MOD... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Respiratory ArrestEvent Description: IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT STOPPED BREATHING AND A CODE WAS CALLED. IT IS UNKNOWN AT WHAT SPECIFIC POINT THE COMPLICATION OCCUR... | BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. AS OF 14-DEC-2022, A SYSTEM LOG REVIEW CAN... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Cardiac ArrestEvent Description: IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY WENT INTO CARDIAC ARREST WHILE THE CATHETER WAS BEING REMOVED FROM THE ENDOTRACHEAL TUBE. THERE... | BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A REVIEW OF THE EVENT INFORMATION WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) A... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL GASTRECTOMY SURGICAL PROCEDURE, THE HORIZON SMALL CLIP APPLIER INSTRUMENT MOVED NON-INTUITIVELY: THE JAWS BENT ON THEIR OWN. THE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HORIZON SMALL CLIP APPLIER INSTRUMENT WAS ANALYZED AND THE COMP... |
Brand Name:DAVINCI XIDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA TAPP SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER THAT WHILE SETTING UP FOR A CASE HE WA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING HAVING ISSUES WITH ARM 4 DRIFTING AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASE... |
Brand Name:SUREFORMDevice Problem: Misfire; Failure to CutPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) PROCEDURE, THERE WAS A TISSUE PUSHOUT EVENT INVOLVING A BLUE SUREFORM 60 RELOAD AND A SUREFORM 60 STAPLER INSTRUMENT. PER THE ... | BASED ON THE CUSTOMER'S CLAIM AGAINST THE PRODUCT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED FOR RETURN OF THE STAPLER RELOAD AND INSTRUMENT FOR FAILURE ANALYSIS. HOWEVER, AS OF THE DATE OF THIS REPORT, ISI HAS NOT RECEIVED THE PRODUCTS F... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA SURGICAL PROCEDURE, THE ERBE GENERATOR HAD A FAULT. A NURSE CALLED BACK INTO TECHNICAL SUPPORT AND INFORMED THE TE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE OCCURRENCE OF ERROR C-34 ON ERBE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THE REPORTED EVENT. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE CONFIRMED THE RE... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION SURGICAL PROCEDURE, AN ERROR C-37 OCCURRED ON THE VIO INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU/ERBE) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS COULD NOT BE REPRODUCE THE CUSTOMER REPORTED COMPLAINT. THE ERBE WAS ENERGIZED AND CAUTERIZED SUCCESSFULLY. ALL PORTS RECOG... |
Brand Name:DAVINCI XIDevice Problem: No Device OutputPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE SITE WAS HAVING RECOGNITION ISSUES ON THEIR SCOPE WHEN INSTALLING ON UNIVERSAL SURGICAL MANIPULATOR (U... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM, PN: 380647-27) WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATIONS WAS ABLE TO REPLICATE AND CONFIRM THE REPORTED ISSUE. WHEN THE UNIT TESTED ON AN IN-HOUSE SYSTE... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER WAS NOT WORKING. THERE WAS NO REPORT OF PATIENT INV... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INSTRUMENT WAS NOT WORKING, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE LARGE HEM-O-LOK CLIP APPLIER WAS ANALYZED AND WAS FOU... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY, THE CADIERE FORCEPS WAS NOTED TO HAVE A BROKEN CABLE. IT WAS REPORTED THAT A FRAGMENT FELL INTO PATIENT AND WAS RETRIEVED DU... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE CADIERE FORCEPS INSTRUMENT WAS ANALYZED, AND FAILURE ANALYSIS FOUND TO HAVE FRAYED GRIP CABLE AT THE DISTAL END. THE FRAYED CABLE STRANDS STUCK OUT AT THE WRIST. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE VARIOUS SCRATCH ... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT DID NOT MOVE AS IT MOVED ON THE CONSOLE. THE PROCEDURE WA... | INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE MCS INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED TH... |
Brand Name:ENDOWRIST SPDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE START (PRE-ANESTHESIA) OF AN UNSPECIFIED DA VINCI-ASSISTED PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) HAD EXPIRED PREMATURELY (CANNOT BE USED). ... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN TUBE OVER MOLDED ADAPTER. MATERIAL W... |
Brand Name:ENDOWRIST SPDevice Problem: Material Integrity ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE (PRE-ANESTHESIA), THE ENDOWRIST SP MONOPOLAR CURVED SCISSORS INSTRUMENT WAS OBSERVE... | ISI RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS CONFIRMED THE REPORTED COMPLAINT. THE MCS INSTRUMENT WAS FOUND TO HAVE A BROKEN TUBE OVERMOLDED ADAPTER. MATERIAL WAS MISSING AND NOT RETURNED BY THE CUSTOMER. MISSING MATERIAL WAS APPROXIMATELY ... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING DA VINCI ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD NON-RECOVERABLE 319 ERRORS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGI... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE REPLACED THE PATIENT SIDE CART (PSC) TOUCHSCREEN, HOWEVER, AFTER FEW POWER CYCLES, THE TOUCHSCREEN START... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A CUSTOMER WAS GETTING 252 AND 23210 ERRORS. THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNI... | BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A DEFECTIVE BLUE CABLE. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND WAS INFORMED THAT THE ISSUE WAS RESOLVED BY REPLACING THE DEFECTIVE BLUE F... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE CUSTOMER CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT FAULTS ON THE SYSTEM. THE CUSTOMER STATED THAT WHILE THEY WERE TURNING THE SYSTEM OFF TO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SYSTEM WOULD ERROR OUT WITH A RED FAULT AND THEN THE SYSTEM WOULD POWER OFF COMPLETELY, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUS... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THERE WAS A NON-RECOVERABLE 26002 ERROR ON ARM 2. THE CUSTOMER WAS NOT ABLE TO TROUBLESHOOT AT ... | FOR THE PROXIMAL SETUP JOINT (SUJ), THE ERROR WAS CONFIRMED VIA LOGS BUT NOT REPLICATED. THE SUJ WAS INSTALLED ON THE IN-HOUSE SYSTEM, AND IT DID NOT TRIGGER ANY ERRORS. NEXT, THE PROXIMAL SUJ WAS INSTALLED ON THE TEST SYSTEM AND PASSED ALL TESTING. Manufacturer Narrative: BASED ON THE CLAIM AGAINST THE PRODUCT BY THE ... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE JOINT OF THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WOULD NOT ARTICULATE PROPERLY. THE PROCEDU... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE JOINT OF LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WOULD NOT ARTICULATE PROPERLY, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PE... |
Brand Name:ENDOWRISTDevice Problem: Material FrayedPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CUSTOMER REPORTED THAT THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT HAD A BROKEN CONDUCTOR WIRE. IT WAS UNKNOWN IF A FRAGMENT FELL INSIDE T... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKEN CONDUCTOR WIRE AND UNKNOWN IF A FRAGMENT FELL INSIDE THE PATIENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIP... |
Brand Name:ENDOWRIST;DAVINCI SIDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT A CRACK HAD FORMED IN THE CABLE OF THE FENESTRATED BIPOLAR FORCEPS AT THE TOP OF THE STOP. AFTER REPROCESSING, A TEAR WAS OBSERVED ON THE CABLE AT T... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE INSULATION DAMAGE ON THE CONDUCTOR WIRE. THE INTERNAL WIRES WERE EXPOSED AS A RESULT. THE DAMAGE W... |
Brand Name:ENDOWRIST SPDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SINGLE PORT (SP) FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS DIFFICULT TO MOVE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING DIFFICULT TO MOVE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SINGLE PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED, A... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE INSTRUMENT'S PLASTIC "JACKET" WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PLASTIC "JACKET" DEFECTIVE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. HOWEVER, THE INSTRUMENT HAS NOT YET BEEN RETURNED FOR EVALUATION. ADDITIONAL I... |
Brand Name:DA VINCI SPDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT ERROR M-11 OCCURRED ON THE INTEGRATED E... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE DID NOT REPRODUCE ERROR M-11 DURING THE VISIT, BUT ERROR M-11 WAS CONFIRMED UPON REVIEWING THE ERROR LOGS. THE FSE REPLACED THE VIO DV INTEGRATED ELECTROSURGICAL UNIT (IE... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, THE SITE ENCOUNTERED RECOVERABLE FAULT 31199 ON ARM 4. THE CUSTOMER POWER CYCLED AND CLEARED THE FAULT SUCCES... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. BASED ON FIELD SERVICE EVALUATION, THE REPORTED ISSUE ¿GETTING RECOVERABLE ERROR 31199 ON ARM 4¿ WAS CONFIRMED. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO R... |
Brand Name:ENDOWRISTDevice Problem: Mechanical ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CURVED TIP STAPLER 30 INSTRUMENT WOULD ADVANCE BUT NOT COME BACK. THE PROCEDURE WAS COMPLETED WIT... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PRODUCT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE ENDOWRIST CURVED TIP STAPLER 30 INSTRUMENT WAS ANALYZED, AND FAILURE ANALYSIS FOUND DURING A REVIEW OF THE LOGS FOR THE RELATED INSTRUMENT, THE CURVED TIP STAPLER 30 INSTRUMENT HAD SEVERAL SHIFTING ... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE PERMANENT CAUTERY SPATULA (PCS) HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH N... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY SPATULA INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED AND CONFIRMED THE REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB TO BE RELATED TO THE CUSTOME... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, A CABLE FROM THE TENACULUM FORCEPS INSTRUMENT WAS NOTED TO BE BROKEN. THERE WAS NO REPOR... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE TENACULUM FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE BROKEN PITCH CABLE AT THE DISTAL END.... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT WAS NOTED TO HAVE A BROKEN CABLE WHILE HOLDING THE MYOM... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE TENACULUM FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE BROKEN DISTAL PITCH CABLE AT THE DIST... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD A BROKEN CABLE WHILE PULLING THE MYOMA. ANOTHER INS... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE TENACULUM FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT ¿BROKEN/LOOSE CABLE¿. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN PITCH CABLE TO BE... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO STARTING A CHOLECYSTECTOMY, THE HEM-O-LOK CLIP APPLIER INSTRUMENT HAD LOCKING ISSUES AND WAS NOT PROVIDING SUFFICIENT GRIP. THE PROCEDURE WAS COMPLETED... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE HEM-O-LOK CLIP APPLIER HAD LOCKING ISSUES, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HEM-O-LOK CLIP APPLIER HAD A BROKEN IN... |
Brand Name:DA VINCIDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In Patient; No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY BENIGN SURGICAL PROCEDURE, THE SURGEON FOUND A "FOREIGN OBJECT" INSIDE THE PATIENT... | BASED ON THE CLAIM BY THE CUSTOMER NOTING THAT A FOREIGN OBJECT WAS FOUND INSIDE THE PATIENT'S ANATOMY, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE SURGEON AND STAFF WAS NOT SURE WHERE THE FRAGMENT CAME FROM OR WHETHER IT WAS IN THE PATIENT'S ANATOMY PRIOR TO THE START OF THE SURGI... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY-RADICAL EXTRAPERITONEAL WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING E-100 TURNED RED AND STOPPED WORKING AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A FIELD SERVICE ENGINEER WAS DISPATCH ON SITE TO INVESTIGATE THE REPORTED PROBLEM. THE ISI FSE WAS ABLE TO REPLICATE THE ISSUE AND REPLACED ER... |
Brand Name:SUREFORMDevice Problem: Patient Device Interaction ProblemPatient Problem: Bowel PerforationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL GASTRECTOMY PROCEDURE, THE TIP OF THE SUREFORM 45 STAPLER INSTRUMENT UNINTENTIONALLY PERFORATED DUODENAL TISSUE. THE ISSUE OCCURRED DURING THE ... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION OR REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE LOGS FOR THE SURE... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: INTUITIVE BECAME AWARE OF A JOURNAL OF ROBOTIC SURGERY ARTICLE TITLED, ¿COMBINING STAGED LAPAROSCOPIC COLECTOMY WITH ROBOTIC COMPLETION PROCTECTOMY AND ILEAL POUCH¿ANAL ANASTOMO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A ROBOTIC MALFUNCTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE CUSTOMER NOTED THAT AFTER SHUTTING DOWN AND RESTARTING THE SYSTEM TWICE, THE THREE REMAINING ROBOT ARMS COULD BE OPERATED AGAIN, BUT ARM NUMBER 2 COULD N... |
Brand Name:DA VINCIDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE UNIVERSAL SEAL HAD INSUFFLATION CONNECTION THAT BROKE LOOSE AND DETACHED FROM THE SEAL INTRAOPER... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNIVERSAL SEAL BROKE LOOSE AND DETACHED , AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF ... |
Brand Name:DA VINCI SPDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT TONGUE BASE RESECTION SURGICAL PROCEDURE, THE SURGEON REPORTED THE LEFT AND THE RIGHT INSTRUMENTS WERE WORKING BACKWARDS. T... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE LEFT AND THE RIGHT INSTRUMENTS WERE WORKING BACKWARDS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER CLUTCHED THE PATIENT SIDE MANIPULATOR (PSM) AND ADJUSTE... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT CABLE WAS BROKEN. A BACKUP INSTRUMENT OF SAME KIND WAS ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKEN CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE A BROKE... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER WOULD NOT OPEN OR CLOSE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED ... | BASED ON THE OPENING AND CLOSING ISSUES ON THE LARGE HEM-O-LOK CLIP APPLIER, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE INVESTIGATION TO DETERMINE THE CAUSE OF THI... |
Brand Name:NONEDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT WHILE THE SURGEON WAS EXCISING THE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE HARMONIC ACE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC A... |
Brand Name:DAVINCI XDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER OBSERVED UNINTUITIVE MOTION ON INSTRUMENTS INSTALLED ON THE UNIVERSAL SURGICAL MANIPULATOR (USM 1) . A... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON INTUITIVE MOTION, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACE... |
Brand Name:ENDOWRIST SPDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, A PLASTIC PIECE FROM THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TIP BROKE AND FELL INTO THE PA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A PLASTIC PIECE FROM THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TIP WAS BROKEN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WOULD NOT ROTATE PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WOULD NOT ROTATE CORRECTLY, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILUR... |
Brand Name:ENDOWRISTDevice Problem: Entrapment of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THAT, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS DULL AND WAS STICKING TO TISSUE. THE PROCEDURE WAS COMPLETED WITH NO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INSTRUMENT STICKING TO TISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS ANALYZED AND ... |
Brand Name:DAVINCI SIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LAMP SUDDENLY SHUT OFF. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). UPON VERIFICAT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ILLUMINATOR ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE TESTED T... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT A PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX. THE LESION WAS LOCATED IN THE RIGHT UPPER LOBE. AT THE TIME OF THIS REPORT, ... | BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A SYSTEM LOG REVIEW CANNOT BE PERFORMED BE... |
Brand Name:SUREFORMDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT TIP WAS NOT MOVING IN THE DIRECTION IT NEEDED TO. IT WAS MOVING IN TH... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON INTUITIVE MOTION, AN INVESTIGATION IS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SUREFORM 45 STAPLER INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HEMICOLECTOMY-RIGHT SURGICAL PROCEDURE, THE ISSUES WITH THEIR ERBE GENERATOR WERE NOTED. INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ISSUES THE ERBE GENERATOR, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE ISI FSE... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE. THE CUSTOMER CALLED IN TO REPORT, THAT ERROR M-36 OCCURRED ON THE INTEGRATED ERBE ELECTROSURGICAL GENE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING, THAT ERROR M-36 OCCURRED ON THE INTEGRATED ERBE ELECTROSURGICAL GENERATOR UNIT (IESU). AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOME... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CABLES OF A FENESTRATED BIPOLAR FORCEPS INSTRUMENT WERE DEFECTIVE AT THE FRONT BEFORE THE JAWS. THE PROCEDURE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKEN CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED, AND FAILURE ANALYS... |
Brand Name:ENDOWRISTDevice Problem: Firing ProblemPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CLIPS WERE FOUND STUCK ON THE MEDIUM-LARGE CLIP APPLIER. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MU... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE CLIPS STICK ON THE MEDIUM-LARGE CLIP APPLIER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE MEDIUM-LARGE CLIP APPLIER WAS ANALYZED, AND FAILURE ANALYSIS REPLICATED AND CONFIRMED THE REPORTED ISSUE. FAILURE ANALYSIS FOU... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WOULD NOT APPLY THE CLIP PROPERLY. THE PROCEDURE WAS COM... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MEDIUM-LARGE CLIP APPLIER WOULD NOT APPLY CLIP PROPERLY, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE CLIP APPLIER INSTRUMENT WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATION WAS ABLE TO REPLICATE AND CONFIRM THE CUST... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO STARTING (POST-ANESTHESIA, NO PORTS PLACED) A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FORCE BIPOLAR INSTRUMENT DID NOT FUNCTION AFTER BEING CONNECTED.... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR WAS ANALYZED AND FOUND TO HAVE A BROKEN BIPOLAR CONDUCTOR WIRE. THE HOUSING W... |
Brand Name:ENDOWRISTDevice Problem: Material Fragmentation; Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT MOVED UNINTUITIVELY. A BACKUP I... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT MOVED WITH UNINTUITIVE MOTION. AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MCS IN... |
Brand Name:DAVINCI XIDevice Problem: No Display/ImagePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) 1 HAD LOSS OF THE RIGHT EYE. AN INTUITIVE SURGICAL, INC. (ISI) T... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING LOSS OF RIGHT EYE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED TH... |
Brand Name:DAVINCI SIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE ILLUMINATOR SUDDENLY TURNED OFF. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE INTUITIVE SURGICAL,... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ILLUMINATOR ASSEMBLY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT ¿ILLUMINATOR WAS SUDDENLY OFF¿. THE ILLUMINATOR WAS TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA)... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. THIS WAS DISCOVERED VIA CT SCAN DURING THE PROCEDURE. THE INITIAL SIZE WAS SMALL... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. PER AN ISI ADVANCED FAILURE ENGINEER, A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE AT THIS TIME. NO IMAGE... |
Brand Name:ENDOWRISTDevice Problem: Failure to Deliver EnergyPatient Problem: Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE COAGULATE FUNCTION FOR THE MARYLAND BIPOLAR FORCEPS INSTRUMENT DID NOT WORK. THE SITE ATTEMPTED TO TURN THE ENERGY SETTIN... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. A PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. HOWEVER, THE INVESTIGATION IS IN PROGRESS. A FOLLOW-UP MDR WILL BE SUBMITTED WHENADDITIONAL INFORMATION IS OBTAINED. AN ADVANCED SY... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, WHEN THE CUSTOMER WAS DRIVING THE PATIENT SIDE CART (PSC) TOWARD THE PATIENT TO ST... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SINGLE NON-RECOVERABLE FAULT DUE TO DAMAGED FIBER CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE ISI TSE HELPED TRANSFERRED THE CUSTOMER TO ISI CUSTOMER SERVICE TO... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED, THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE. THE PATIENT DEVELOPED A PNEUMOTHORAX. THE LESION WAS CLOSE TO THE PLEURA. PER THE PHYSICIAN, A CHEST TUBE WAS PLACED T... | BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SYSTEM LOG REVIEW CANNOT BE PERFORMED B... |
Brand Name:DAVINCI SIDevice Problem: No Display/ImagePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT DURING FOLLOWING MODE, SURGEON OBS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING HIGH-RESOLUTION STEREO VIEWER (HRSV) LEFT EYE ISSUE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE FIELD SERVICE ENGINEER (FSE) REPRODUCED AND REPLACED THE HRSV TO RESOLVE THE REPORTED PROBLEM. SYSTEM TESTED AND VERIFIED ... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE MARYLAND BIPOLAR FORCEPS WAS BEING ASSESSED DURING CENTRAL REPROCESSING AND THE CUSTOMER NOTICED SIGNS OF THERMAL SPREADING OR BURNS TO THE INSTRUMENT'... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THERMAL DAMAGE ON THE MARYLAND BIPOLAR FORCEPS, AN INVESTIGATION IS IN PROGRESS. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE ... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE IMAGE WAS UPSIDE DOWN. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING IMAGE ORIENTATION ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER INFORMED THE TSE THAT THE ISSUE WAS RESOLVED AFTER THEY REMOVED THE ENDOSCOPE, PRESSED TH... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INSULATION ON THE WIRE WAS CRACKED. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING CRACKED INSULATION, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE T... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT THE FORCE BIPOLAR INSTRUMENT WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INIT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING DEFECTIVE INSTRUMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKE... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT WAS FOUND TO HAVE A CABLE BROKEN. THE PROCEDURE WAS CON... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING, BROKEN CABLE. AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN P... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT THE FORCE BIPOLAR INSTRUMENT HAD A BROKEN TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKEN TIP, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP AT ... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD A BROKEN/LOOSE CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. FOLLOW... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKEN CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN PI... |
Brand Name:SINGLE-SITEDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT HAD THE TIP AND THE BODY PARTS SEPARATED. ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE, AN INVESTIGATION IS IN PROGRESS. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT RELATED TO THIS COMPLAINT FOR EVALUATION, BUT FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED. THEREFORE, THE ROOT CAUSE OF ... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, INSPECTION OF THE 8MM FORCE BIPOLAR INSTRUMENT IDENTIFIED PHYSICAL DAMAGE AT THE TIP. THERE WAS NO PATIENT INVOLVEMENT.... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND CONFIRMED A BROKEN GRIP TIP, ... |
Brand Name:DAVINCI SIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM HAD PATIENT SIDE MANIPULATOR (PSM) 3 LED OFF, ALL OTHER ARMS WERE WORKING FINE. AN ERROR 22003 REP... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING LED OFF, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. ISI DID NOT RECEIVE A DA VIN... |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.