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Brand Name:SINGLE-SITEDevice 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 WRISTED NEEDLE DRIVER INSTRUMENT WAS STIFF AND DID NOT MOVE IN THE INTENDED DIRECTION. A BACKUP IN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE WRISTED NEEDLE DRIVER INSTRUMENT DID NOT MOVE IN THE INTENDED DIRECTION, AN INVESTIGATION IS IN PROGRESS. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT RELATED TO THIS COMPLAINT FOR EVALUATION, BUT FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COM... |
Brand Name:ENDOWRISTDevice Problem: No Device OutputPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL CONDUIT SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) DID NOT WORK AND FAILED THE SELF-TEST. DURING CALL THE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A RECOGNITION ISSUE, 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 VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS ANALYZED AND FOUND TO ... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of Device; Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO START A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A FORCE BIPOLAR INSTRUMENT WOULD NOT FUNCTION PROPE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INSTRUMENT NOT FUNCTIONING PROPERLY, 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 FO... |
Brand Name:NONEDevice Problem: Material SeparationPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE TIP COVER ACCESSORY CAME RIGHT OFF FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE CUSTOMER WAS UNSURE HOW IT ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE, AND ISI DID RECEIVE THE DEVICE ON WHICH TO PERFORM FAILURE... |
Brand Name:ENDOWRISTDevice Problem: Material FrayedPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD A FRAYED CABLE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING FRAYED 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 MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BR... |
Brand Name:ENDOWRISTDevice Problem: BreakPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT TIP BROKE. THERE WAS NO PROBLEM. AND THE CUSTOMER DID NOT NEED ANY OTHER INSTRUMENT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN TIP, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ISI HAS NOT RECEIVED THE PROD... |
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 LEFT HEMICOLECTOMY SURGICAL PROCEDURE, THE SYSTEM FAULTED TWICE DURING THE START OF THE CASE. THE CUSTOMER CONTINUED AND WAS AWAR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR ON ARM 3 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 THE UN... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, INSPECTION OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT IDENTIFIED THAT THE TIP WAS MELTED. THERE WAS NO REPORT OF PATIENT INVOLV... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING MONOPOLAR CURVED SCISSORS INSTRUMENT MELTED TIP, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ALTHOUGH THE COMPLAINT REGARDING REPORTED FAILURE WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE INSTRUMENT WAS NOT RETURNED, 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 SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED AN IMAGE ORIENTATION ISSUE WITH THE ENDOSCOPE. THE DA VINCI COORDINATOR STATED THAT THE ISSU... | AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN RMA WAS NOT ISSUED FOR RETURN AS THE CUSTOMER REPORTED THAT THEY WOULD NOT RETURN THE INSTRUMENT. ALTHOUGH THE COMPLAINT... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Failure to Anastomose; RuptureEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SUBTOTAL GASTRECTOMY/GASTRIC BYPASS (ROUX-EN-Y) PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND WAS RE-ADMITTED WITH A STAPLE LINE LEAK. PER THE I... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE COMPLICATION CANNOT BE DETERMINED. A PRODUCT HAS NOT BEEN RETURNED TO ISI FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE ADVANCED INSTRUMENT LOG FOR THE SUREFORM 60 STAPLER INSTRUMENT ASS... |
Brand Name:SUREFORMDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Unspecified Gastrointestinal ProblemEvent Description: IT WAS REPORTED THAT THE PATIENT UNDERWENT A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE. AFTER THE PROCEDURE, THE PATIENT HAD A LEAK IN THE STOMACH. INTUIT... | 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. VERIFICATION OF THE EVENT DETAILS VIA SYSTEM LOGS CANNOT BE PERFORMED AT THIS TIME BECAUSE THERE WAS NO SLEEVE GASTRECTOMY PROCEDURE DONE BY T... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY - RADICAL WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT DID NOT OBEY COMMANDS WHEN ... | 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. INTUITIVE SURGICAL INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF T... |
Brand Name:NONEDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED TO AN ISI CLINICAL SALES REPRESENTATIVE (CSR) THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE USING AN DA VINCI SP SYSTEM, THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT WA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ALTHOUGH THE COMPLAINT REGARDING THE REPORTED FAILURE WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE MCS TIP COVER ACCESSORY WAS ALREADY DISPOSED OF AND WILL NOT BE RETURNING TO ISI FOR... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARAESOPHAGEAL HIATAL HERNIA SURGICAL PROCEDURE, THERE WERE MULTIPLE ERBE ERRORS NEAR THE COMPLETION OF THE PROCEDURE. THE CUSTOMER EXPLAINED TH... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED ERBE GENERATOR ERRORS NEAR THE COMPLETION OF THE PROCEDURE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A FIELD SERVICE ENGINEER (FSE) HAS BEEN DISPATCHED TO THE CUSTOMER SITE TO FURTHER TROUBLESHOOT THE ISSUE. THE... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UMBILICAL HERNIA SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT BROKE AT THE JAWS. THE STAFF REMOVED THE INSTRUMENT AND CANNULA TOGETHER. THE PROCE... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) HAS NOT RECEIVED THE FORCE BIPOLAR INSTRUMENT INVOLVED WITH THIS COMPLAINT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. AN ISI FIELD SERVICE ENGINEE... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT CENTRAL PROCESSING THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A DAMAGED BLACK WIRE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL INC... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING POSSIBLE CONDUCTOR WIRE DAMAGE, 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 ... |
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 MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS NOTED WITH A DAMAGED BLACK WIRE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE S... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING POSSIBLE CONDUCTOR WIRE DAMAGE, 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 ... |
Brand Name:DAVINCI XIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT THE PATIENT UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBE PULMONARY LOBECTOMY PROCEDURE ON (B)(6) 2023. THE SURGEON REPORTED VIA THE INTUITIVE SURGI... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POSTOPERATIVE COMPLICATION CANNOT BE DETERMINED. THE SURGEON REPORTED NO DEVICE ISSUES OR OTHER COMPLICATIONS DURING THE PROCEDURE AND SUSPECTS A POSSIBLE POSTOPERATIVE COMPLICATION RELATED TO PATIENT COMORBIDITIES. AN AUTOPSY IS REPORTED TO BE PENDING. A FOLL... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, DURING CENTRAL PROCESSING, THE LARGE NEEDLE DRIVER INSTRUMENT HAD A BROKEN PAD ON THE TIP OF THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPOR... | BASED ON THE CLAIM AGAINST THE PRODUCT NOTING THE BROKEN PAD ON THE 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 LARGE NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE CARBIDE ... |
Brand Name:ENDOWRISTDevice Problem: BreakPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED RADICAL SALVAGE PROSTATECTOMY SURGICAL PROCEDURE. THE WRIST ON A PROGRASP FORCEPS INSTRUMENT HAD BROKEN AND THE INSTRUMENT COULD NOT BE REMOVED FROM THE ... | BASED ON THE CLAIM AGAINST THE PRODUCT, BY THE CUSTOMER NOTING THE PROGRASP FORCEPS INSTRUMENT HAD BROKEN AND COULD NOT BE REMOVED FROM THE TROCAR. 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... |
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 PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS BEING USED TO CUT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING MONOPOLAR CURVED SCISSORS (MCS) TIP COVER FELL OFF. AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AT THE POINT OF REMOVING THE MCS INSTRUMENT FROM THE ROBOT, THE MCS TIP COVER ACCESSORY LOOSENED AND FELL OFF THE MCS INSTRUMENT... |
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 THYROIDECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS FOUND TO HAVE THE TEFLON PAD DAMAGED. A BACKUP INSTRUMENT ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING DAMAGED TEFLON PAD, AN INVESTIGATION IS IN PROGRESS. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE HARMONIC ACE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE ... |
Brand Name:NONEDevice Problem: Unintended MovementPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED AN IMAGE ORIENTATION ISSUE WITH THE ENDOSCOPE. THE DA VINCI COORDINATOR STATED, THAT THE ISSUE HAD ... | AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN RMA WAS NOT ISSUED FOR RETURN. AS THE CUSTOMER REPORTED, THAT THEY WOULD NOT RETURN THE INSTRUMENT. ALTHOUGH THE COMPLAI... |
Brand Name:ENDOWRISTDevice Problem: BreakPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN FENESTRATED BIPOLAR FORCEPS 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 FENESTRATED BIPOLAR FORCEPS INSTRUME... |
Brand Name:SUREFORMDevice Problem: Firing ProblemPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE, A TISSUE PUSHOUT EVENT OCCURRED WHILE USING A SUREFORM 60 STAPLER INSTRUMENT LOADED WITH A BLUE SUREFORM 60 STAPLER RELOAD. THE STAPLER "D... | BASED ON THE CUSTOMER'S CLAIM AGAINST THE PRODUCT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE CSR WAS INFORMED THAT THE STAPLER AND RELOAD ARE BOTH AVAILABLE FOR RETURN TO ISI FOR EVALUATION; HOWEVER, THE DEVICES HAVE NOT YET BEEN RECEIVED. IF ADDITIONAL INFORMATION IS OBTAINED, ... |
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 SURGICAL PROCEDURE, THE METAL TIP PARTIALLY BROKE OFF ROBOTIC ARM OF A TIP-UP FENESTRATED GRASPER INSTRUMENT. THE PROCE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING METAL TIP PARTIALLY BROKE OFF ROBOTIC ARM, 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 TIP-UP FENESTRATED GRASPER INSTRUMENT WAS ... |
Brand Name:ENDOWRISTDevice Problem: BreakPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT AFTER SUCCESSFULLY COMPLETING A DA VINCI-ASSISTED SURGICAL PROCEDURE. THE USER OBSERVED DAMAGE ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT CONDUCTOR WIRE INSULATION, AND THE INTE... | BASED ON THE CLAIM AGAINST THE PRODUCT, BY THE CUSTOMER NOTING CONDUCTOR WIRE INSULATION DAMAGE. AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED EVENT WAS C... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE SHEATH OF ELECTRICAL CABLING SUPPLYING THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT JA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD ELECTRICAL CABLING THAT WAS BROKEN AND NOT INSULATED, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAS NOT YET BEEN RETURNED TO I... |
Brand Name:DAVINCI XIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE MIDDLE LOBE WAS INFLAMED, AND THE LOWER LOBE WAS SWOLLEN DUE... | ALTHOUGH THERE IS NO CLAIM AGAINST THE PRODUCT AND NO INDICATION OF A PRODUCT ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THE CONVERSION. BASED ON THE INVESTIGATION, THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE ISSUE. WHILE THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYS... |
Brand Name:SINGLE-SITEDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE SITE ENDOMETRIOSIS RESECTION AND OVARIAN CYSTECTOMY SURGICAL PROCEDURE, A SINGLE SITE FENESTRATED BIPOLAR FORCEPS (SS FBF) INSTR... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PART ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE INITIAL CUSTOMER REPORTED COMPLAINT OF "IT STOPPED MOVING THEY THINK ONE OF THE PULLEYS QUIT WORKING. IT QUIT RESPONDING WHEN THEY TRIED OPENING AND CLOSING IT". TH... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM HAD REPEATED 23,30, 281, AND 307 ERRORS ON MCL2. THE PROCEDURE WAS CONVERTED TO LAP... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED 23, 30, 281, AND 307 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. ... |
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 WITHOUT LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE. THE CUSTOMER HAD AN ERROR "C-34" WHEN THEY TRY TO COAGULATE WI... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED A SECOND INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION WAS ABLE TO REPRODUCE AND CONFIRM THE CUSTOMER REPORTED C-34 ERROR ISSUE. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND ... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, ONE OF THE BLACK CABLES WAS DAMAGED WITH SMALL PINCH. THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MUL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ONE OF THE BLACK CABLES GETTING DAMAGED, 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). THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT ... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT COULD NOT BE OPENED/CLOSED INTR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE MOTION OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. ... |
Brand Name:SUREFORMDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HEMICOLECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER EXPERIENCED NON-INTUITIVE MOTION. A BACKUP STAPLER WAS USED TO COMPLETE THE PR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SUREFORM 45 STAPLER EXPERIENCED 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 SUREFORM 45 STAPLER WAS ANA... |
Brand Name:ENDOWRISTDevice Problem: Entrapment of DevicePatient Problem: Unspecified Tissue InjuryEvent Description: AS PART OF AN ANONYMOUS SURVEY, A SITE REPORTED THAT THE LONG BIPOLAR GRASPER HAD TOO MUCH ADHESION OF THE TISSUE TO THE FORCEPS AFTER COAGULATION. THE SITE CONVERTED THE PROCEDURE TO OPEN SURGERY. NO OT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THERE WAS TOO MUCH ADHESION OF TISSUE AFTER CAUTERIZATION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OOPHORECTOMY SURGICAL PROCEDURE, THE IMAGE WAS UPSIDE DOWN AND THE INSTRUMENTS MOVED OPPOSITE. THE ISSUE WAS OPPOSITE MOVEMENT ON BOTH IN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING IMAGE UPSIDE DOWN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER RESEATED THE ENDOSCOPE, AND THE MOVEMENT WAS NORMAL. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WA... |
Brand Name:SUREFORMDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER EXPERIENCED NON-INTUITIVE MOTION. A BACKUP STAPLER WAS USED TO COMPLETE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SUREFORM 45 STAPLER EXPERIENCED NON-INTUITIVE MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE SUREFORM 45 STAPLER WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATIONS WAS UNABLE TO REPLICATE OR CONFIRM THE REPORTED I... |
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 CLIP. THE PROCEDURE WAS COMPLETED WITH NO REP... | BASED ON THE CLAIM AGAINST THE PRODUCT, BY THE CUSTOMER NOTING CLIPPING ISSUES ON THE MEDIUM-LARGE CLIP APPLIER. AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED AND FOUND FAILURE ANALYSIS INVESTIGATIONS, THEY WERE ABLE TO REPLICATE AND ... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK MOVED WITH NON-INTUITIVE MOTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY NOR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ROTATION ISSUES, 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 TO T... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: Foreign Body In Patient; No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE CABLE OF THE FORCE BIPOLAR (FB) INSTRUMENT WAS BROKEN. THE CUSTOMER STATED... | 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 FB INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT T... |
Brand Name:DA VINCI 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 SYSTEM HAD REPEATED ERROR C-34 ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THERE WAS NO DEVICE... | BASED ON THE CLAIM AGAINST THE PRODUCT, BY THE CUSTOMER NOTING THAT THE SYSTEM REFLECTED REPEATED ERROR C-34 ON THE INTEGRATED ELECTRO SURGICAL UNIT (IESU). 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... |
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 BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE SYSTEM DISPLAYED AN ERROR, AND THE USER WAS UNABLE TO MOVE UNIVERSAL SIDE MANIP... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE USM 4 UNAVAILABILITY, 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. DURING FIELD... |
Brand Name:DAVINCI XIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Hemorrhage/Bleeding; Unspecified Infection; Obstruction/OcclusionEvent Description: ON 16-MAR-2023, INTUITIVE SURGICAL, INC (ISI) BECAME AWARE OF A JOURNAL OF ROBOTIC SURGERY ARTICLE TITLED, ¿COMBINING STAGED LAP... | ADDITIONAL INFORMATION WAS OBTAINED FROM THE AUTHOR OF THE JOURNAL OF ROBOTIC SURGERY ARTICLE TITLED, ¿COMBINING STAGED LAPAROSCOPIC COLECTOMY WITH ROBOTIC COMPLETION PROCTECTOMY AND ILEAL POUCH¿ANAL ANASTOMOSIS (IPAA) IN ULCERATIVE COLITIS FOR IMPROVED CLINICAL AND COSMETIC OUTCOMES: A SINGLE-CENTER FEASIBILITY STUDY ... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE TIP OF THE SUCTION IRRIGATOR INSTRUMENT BROKE OFF AND BECAME DISLODGED IN THE PATIENT. THE FR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE TIP OF THE SUCTION IRRIGATOR BROKE OFF, 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 SUCTION IRRIGATOR INSTRUMENT WAS ANA... |
Brand Name:DA VINCI XIDevice Problem: No Display/ImagePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY - BENIGN SURGICAL PROCEDURE, THE LEFT EYE ON THE SECOND SURGEON SIDE CONSOLE (SSC) CONSOLE WAS BLACK. THE CUSTOMER TRIED TO REBO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING LEFT EYE BLACK ON SSC1, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN ISI FIELD SERVICE ENGINEER (FSE) HAS BEEN DISPATCHED TO INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE HIGH STEREO RESOLUTION VIEWER (HRSV) TO RES... |
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 COLORECTAL SURGICAL PROCEDURE, THE LARGE HEM- O LOK- CLIP APPLIER INSTRUMENT WOULD NOT FIRE THE CLIP WHEN DOCKED ON THE ROBOT. THE PR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING WOULD NOT FIRE THE CLIP, AN INVESTIGATION IS PENDING TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE... |
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 UMBILICAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER REPORTED PROBLEMS WITH UNIVERSAL SURGICAL MANIPULATOR (USM) 2. PRIOR TO CALLING, THE CUSTOME... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 WAS HAVING ISSUES, 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 INVESTIGATE THE... |
Brand Name:DAVINCI XIDevice Problem: Improper or Incorrect Procedure or MethodPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE PATIENT HAD A BLUNT INJURY TO THE SEGMENT 4 OF THE LIVER. THE SURGEON WAS TRYING TO ADJUST HIS HAND ON... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION WAS TRACED TO UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE OR A SUMMARY OF RELEVANT ERRORS THAT WERE OBSERVED. TECHNICAL... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND HOSPITALIZATION. PATIENT MEDICAL HISTORY INCLUDE... | 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION... |
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 GASTRIC BYPASS SURGICAL PROCEDURE, THE CUSTOMER LOST VIDEO IN THE RIGHT EYE OF THE HIGH-RESOLUTION STEREO VIEWER (HRSV). THE PROCEDURE WAS COM... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING IMAGE LOSS IN THE RIGHT EYE OF THE HIGH-RESOLUTION STEREO VIEWER (HRSV), 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 FURTH... |
Brand Name:DAVINCI XIDevice Problem: Failure to Deliver EnergyPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE E-100 WAS NOT TURNING ON. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING POWER 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 FIELD SERVICE ENGINEE... |
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 MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS NOT CLOSING OR RELEASING THE CLIP. THE PROCEDURE WAS COMPLETED WITH ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS NOT CLOSING OR RELEASING THE CLIP, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATIONS WERE UNABL... |
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 NEPHRECTOMY SURGICAL PROCEDURE, THE CLIP WOULD NOT LOCK. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING CLIP WOULD NOT LOCK, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE HAS RECEIVED THE PART ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER ... |
Brand Name:ENDOWRISTDevice Problem: Defective DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT IS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT FENESTRATED BIPOLAR FORCEPS INSTRUMENT IS BROKEN, 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 FENESTRATED BIPOLAR FORCEPS INSTR... |
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 FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD AN EXPOSED WIRE IN THE JAW. THE PROCEDURE WAS COMPLETED WITH NO REPORTE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN EXPOSED WIRE, 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 FOUND TO HAV... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE JAWS OF THE MONOPOLAR CURVED SCISSORS (MCS) DID NOT MOVE IN ALL DIRECTIONS. THE PROCEDURE WAS COMPLETED WITH NO... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE MCS WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL I... |
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 SACROCOLPOPEXY SURGICAL PROCEDURE, THE FORCE BIPOLAR FORCEPS (FBF) INSTRUMENT JAWS DID NOT OPEN. THE CUSTOMER USED A BACKUP FBF INSTR... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FORCE BIPOLAR INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION FOUND THE PRIMARY FAILURE OF INSTRUMENT GRIPS STUCK TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE STUCK GRIPS TH... |
Brand Name:DA VINCI ENERGYDevice Problem: Arcing; SparkingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, TWO FIRE SPARKS WERE RELEASED WHEN THE SURGEON WAS USING SYNCHROSEAL INSTRUMENT OVER A PREVIOU... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING TWO FIRE SPARKS, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE... |
Brand Name:ENDOWRISTDevice Problem: BreakPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8MM TIP-UP FENESTRATED GRASPER HAD BROKEN TIP. THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS ... | 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 TIP-UP FENESTRATED GRASPER WAS ANALYZED AND FOUND TO HAVE BOTH GRIPS BROK... |
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, THE TIP-UP FENESTRATED GRASPER INSTRUMENT HAD A BROKEN TIP. THERE WAS NO REPORT OF PATIENT INJURY. | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKEN AT TIP-UP, 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 TIP-UP FENESTRATED GRASPER INSTRUMENT WAS ANALYZED AND FOUND TO HAV... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Remove; Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE TIP-UP FENESTRATED GRASPER (TUFG) INSTRUMENT TIP WAS DIS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE TIP-UP FENESTRATED GRASPER (TUFG) INSTRUMENT TIP AS DISPLACED FROM THE SHAFT, 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. TH... |
Brand Name:ENDOWRISTDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HORIZON SMALL CLIP APPLIER INSTRUMENT HAD UNDESIRED DANGEROUS MOVEMENT. THERE WAS NO REPORTED PATIENT IMPACT OR HARM. INT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNDESIRED HORIZON SMALL CLIP APPLIER MOVEMENT, 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 ... |
Brand Name:ENDOWRISTDevice Problem: Failure to SensePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED DONOR HEPATECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT COULD NOT APPLY CLIP. THE PROCEDURE WAS COMPLETED WITH NO REPORT... | BASED ON THE CLAIM AGAINST THE PRODUCT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT HAS NOT YET BEEN RETURNED TO ISI FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT YET BE DETERMINED. A FOLLOW-UP MDR WILL BE SUB... |
Brand Name:ENDOWRIST;DAVINCI SIDevice Problem: Unintended System MotionPatient Problem: Hemorrhage/Bleeding; RuptureEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED A SPLENIC ARTERIAL RUPTURE. THE ISSUE OCCURRED WHEN PATIENT SIDE MANIPULATOR (PSM) #... | THIS REPORT CAPTURES THE HARMONIC ACE INSTRUMENT USED IN THE PROCEDURE. A SEPARATE MEDWATCH REPORT WITH MFR REPORT NUMBER 2955842-2023-11856 WAS SUBMITTED FOR THE PATIENT SIDE CART (PSC) PATIENT SIDE MANIPULATOR (PSM) . SECTION D10 - THE CUSTOMER REPORTED THAT THERE WAS ONE EVENT WITH ONE HARMONIC ACE INSTRUMENT, HOWEV... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED DURING CENTRAL PROCESSING A BROKEN TIP FROM THE TIP-UP FENESTRATED GRASPER INSTRUMENT WAS FOUND IN THE SONIC WASHER. THERE WAS NO REPORT OF PATIENT INV... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN TIP ON THE 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 TIP-UP FENESTRATED GRASPER INSTRUMENT WAS ANALYZED AN... |
Brand Name:DAVINCI XIDevice Problem: Failure to Deliver EnergyPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE) GENERATOR BIPOLAR ENERGY CORD WAS NOT DETEC... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING FIRING ISSUE, 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 TESTED THE SYST... |
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, THE SYSTEM HAD A RECOVERABLE FAULT. THE CUSTOMER HAD RESTARTED THE SYSTEM, BUT THE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A RECOVERABLE FAULT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS INITIALLY ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER PERFORMED A HARD SHUTDOWN OF THE PATIENT SIDE CART (PSC), REMOVED THE POWER CORD FR... |
Brand Name:SUREFORMDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MOVEMENTS OF THE STAPLER SUREFORM 60 WERE ALLEGEDLY "IMPOSSIBLE OR CONTRARY TO THE SURGEON'S COMMAND." THE PROCE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE INSTRUMENT MOVEMENT, 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 ... |
Brand Name:DAVINCI XDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BENIGN UPPER GASTROINTESTINAL PROCEDURE, THE PATIENT WAS READMITTED TO THE HOSPITAL AND UNDERWENT A SUBSEQUENT UNPLANNED, U... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THE DEVICE INVOLVED WITH THIS EVENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SYSTEM LOGS WAS NOT ABLE TO BE COMP... |
Brand Name:DA VINCI ENERGYDevice Problem: ArcingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THERE WERE SPARKS COMING OUT OF THE JAWS OF THE SYNCHROSEAL INSTRUMENT WHEN THE SURGEON SEALED THE TISSUE A... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SYNCHROSEAL INSTRUMENT SPARKED AT THE JAWS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI SYNCHROSEAL INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE SYNCHROSEAL INSTRUMENT... |
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 DISTAL GASTRECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER (MLCA) DID NOT WORK AS INTENDED. THE PROCEDURE WAS COMPLETED WIT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE MLCA INSTRUMENT JAWS DID NOT CLOSE, AN INVESTIGATION WAS COMPLETED DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MLCA INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED... |
Brand Name:SUREFORMDevice Problem: Insufficient InformationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, THE SUREFORM 45 CURVED-TIP INSTRUMENT PRODUCED A "MISSHAPED" STAPLE LINE WHICH H... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE "MISSHAPED" STAPLE LINE IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED A PRODUCT FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. AN ADVANCED STAPLER LOG INVESTIGATION WAS PERFORMED BY AN IS... |
Brand Name:ENDOWRIST;DAVINCI SIDevice 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 PERMANENT CAUTERY SPATULA "SPARKLED" OR ARCED. WHEN THE NURSE TOOK OUT TH... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THERMAL DAMAGE, 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 (PCS) INSTRUMENT WAS ANALYZED AND FOUND TO ... |
Brand Name:SUREFORMDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Obstruction/OcclusionEvent Description: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED GASTRIC BYPASS PROCEDURE, THE PATIENT RETURNED TO THE ER WITH AN OBSTRUCTION. THE SURGEON BELIEVES THE OBSTRUCTIO... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OBSTRUCTION CANNOT BE DETERMINED. THERE IS NO REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, NO PRODUCTS ARE EXPECTED FOR RETURN FOR FAILURE ANALYSIS EVALUATION. THE SYSTEM LOGS SHOW A SUREFORM 60 STAPLER INSTRUME... |
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 SIGMOID COLECTOMY SURGICAL PROCEDURE, THE LEFT EYE WAS BLACK ON THE SURGEON SIDE CONSOLE (SSC). THE NURSE STATED THAT THEY TRIED TO RESTART WI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A VISION ISSUE ON THE SURGEON SIDE CONSOLE (SSC), 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 REPO... |
Brand Name:DAVINCI XIDevice Problem: Failure to Deliver EnergyPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE SYSTEM EXPERIENCED INTERMITTENT BIPOLAR FUNCTIONALITY. AN INTUITIVE SURGICAL, INC. (ISI) TECHNIC... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION WAS UNABLE TO REPRODUCE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT ¿SYSTEM EXPERIENCED INTERMITTENT BIPOLAR FUNCTIONALITY¿ I... |
Brand Name:ENDOWRISTDevice Problem: Defective DevicePatient 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 JAWS WERE NOT OPENING ALL THE WAY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT NOT OPENING ALL THE WAY, 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 ... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE OUTSIDE HOUSING OF THE VESSEL SEALE EXTEND (VSE) INSTRUMENT WAS DEFECTIVE, SOME PARTS WERE DETACHED FROM THE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SHAFT OF THE INSTRUMENT WAS BROKEN, 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 CONTRIBU... |
Brand Name:SUREFORMDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT DURING A PULMONARY LOBECTOMY, THE PROCEDURE WAS CONVERTED TO OPEN DUE TO BLEEDING. THE FOLLOWING INFORMATION WAS OBTAINED FROM THE SURGEON: THE BLEEDING CAME FROM AN ABNORMAL... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE BLEEDING LEADING TO THE PROCEDURAL CONVERSION WAS ABNORMAL PATIENT ANATOMY. NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. LOGS SHOW SUREFORM (PART NUMBER ... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THE IMAGE PRODUCED BY THE ENDOSCOPE WAS MIRRORED CAUSING INSTRUMENTS INC... | INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE 0-DEGREE ENDOSCOPE UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE CAMERA INSTRUMENT ADAPTER WAS NOTED TO BE DAMAGED OR FRICTION ISSUE. ADDITIONALLY, AN ARTIFACT WAS ... |
Brand Name:ENDOWRISTDevice Problem: Device Dislodged or DislocatedPatient Problem: Cardiac Arrest; Hemorrhage/Bleeding; Foreign Body In PatientEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM THE PULMONARY ARTERY UPON AWAKENING FROM A... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. A PRODUCT HAS NOT BEEN RETURNED TO ISI FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED,... |
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 SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THAT A FRAGMENT FROM THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT... | 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 IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE HARMONIC ACE INSTRUMENT FOR EVALUATION, BUT EVALUATIO... |
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 RADICAL EXTRAPERITONEAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, SURGEON COULD NO LONGER CONTROL THE INSTRUMENTS USING CONSOLE 1... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, 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 LOOKED AT THE WIRING DIAGRAM SIN... |
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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE THAT AN ERROR OCCURRED AGAINST THE LEFT MASTER TOOL MANIPULATOR (MTML). THE SITE COMPLETED... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THERE WAS AN ERROR AGAINST THE LEFT MASTER TOOL MANIPULATOR (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 FURTHE... |
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 SIGMOID COLECTOMY SURGICAL PROCEDURE, CUSTOMER REPORTS, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS DEFECTIVE AND HAD A NO SEALING I... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE VSE INSTRUMENT WAS DEFECTIVE AND HAD A NO SEALING ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI VSE TO PERFORM FAILURE ANALYSIS. THE VSE WAS ANALYZED AND THE COM... |
Brand Name:ENDOWRISTDevice Problem: ArcingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, A SPARK WAS NOTED WHILE USING THE PERMANENT CAUTERY SPATULA INSTRUMENT. THE CUSTOMER CONFIRMED THAT THE SURGEON... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SPARKING OF THE SPATULA, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED LOGS AND FOUND NO RELATED ERRORS. TSE INFORMED THE CUSTOMER ... |
Brand Name:ENDOWRISTDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE POTTS SCISSORS INSTRUMENT WERE DAMAGED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. I... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING DAMAGED, 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 POTTS SCISSORS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP TIP A... |
Brand Name:ENDOWRISTDevice Problem: Retraction ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT BLADE WAS EXPOSED. IT WAS UNKNOWN IF ANY FRAGMENT FELL INTO THE PATIENT. THE PR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE BLADE EXPOSED, 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 DEVI... |
Brand Name:ENDOWRISTDevice Problem: No Device OutputPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS NOT REGISTERING. THE PROCEDURE WAS COMPLETED WITH NO R... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING RECOGNITION ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE VSE INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE VSE INSTRUMENT WAS ANALYZED AND F... |
Brand Name:ENDOWRISTDevice Problem: FracturePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE OPEN RANGE OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIPS WAS TOO MUCH. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING WIDE RANGE OF THE INSTRUMENT JAWS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATI... |
Brand Name:ENDOWRISTDevice Problem: BreakPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT POINT HAD BEEN CRACKED AND COULD NOT BE REMOVED FROM THE TROCAR. TH... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INSTRUMENT POINT HAD BEEN CRACKED AND COULD NOT BE REMOVED FROM THE TROCAR, 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... |
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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER WAS UNABLE TO MOVE THE BOOM ON THE PATIENT SIDE CART (PSC). THE SYSTEM PROMPT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE BOOM NOT MOVING 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. BASED ON THE FIELD... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY BENIGN SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REP... | 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 HOOK INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BR... |
Brand Name:NONEDevice 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 UROLOGICAL SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS USED FOR A SURGIC... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT'S BODY, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MCS TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE ... |
Brand Name:DA VINCI ENERGYDevice Problem: Material SeparationPatient Problem: Foreign Body In Patient; Insufficient Information; No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER FOUND THAT THE EXTERIOR PART OF THE SYNCHROSEAL IN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT A PART OF THE SYNCHROSEAL INSTRUMENT CAME OFF, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE SYNCHROSEAL INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUS... |
Brand Name:DAVINCI SIDevice Problem: Unintended System MotionPatient Problem: Hemorrhage/Bleeding; RuptureEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED A SPLENIC ARTERIAL RUPTURE. THE ISSUE OCCURRED WHEN THE PATIENT SIDE MANIPULATOR (PSM) 1 WITH ... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED, AND IT IS UNCLEAR WHETHER THE REPORTED INTERMITTENT NON-INTUITIVE MOTION THAT OCCURRED WAS ATTRIBUTED TO THE HARMONIC ACE INSTRUMENT OR THE PATIENT SIDE CART (PSC) PATIENT SIDE MANIPULATOR (PSM) ON WHICH THE INSTRUM... |
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 NEPHRECTOMY SURGICAL PROCEDURE, THE PROGRASP FORCEPS WOULD NO LONGER OPEN OR CLOSE PROPERLY. A NEW INSTRUMENT WAS OBTAINED TO REPLACE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INSTRUMENT 8MM PROGRASP FORCEPS NO LONGER OPENED AND CLOSED PROPERLY, 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 8MM PROGRASP FO... |
Brand Name:SUREFORM RELOADDevice Problem: Insufficient InformationPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED BY A SURGEON THAT FOLLOWING A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE, ONE OF THE "PATIENTS THAT HE USED A [SUREFORM] STAPLER ON HAD A LEAK." THE TYPE OF SUREFORM STAPLER INSTR... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE COMPLICATION CANNOT BE DETERMINED. A PRODUCT HAS NOT BEEN RETURNED TO ISI FOR EVALUATION. A REVIEW OF THE SYSTEM LOGS AND THE DEVICE LOGS FOR A SUREFORM STAPLER RELOAD CANNOT BE PERFORMED AT THIS TIME DUE TO INSUFFICIENT INFORMATION. NO PRODUCT ... |
Brand Name:ENDOWRISTDevice Problem: BreakPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CUSTOMER FOUND THAT THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT HARM. A FOLLOW-UP ATTEMPT IS IN PROGRESS TO OBTAIN AD... | BASED ON THE CLAIM BY THE CUSTOMER NOTING A BROKEN MEGA SUTURECUT NEEDLE DRIVER 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 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS ANALYZED AN... |
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