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Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT YAW PULLEY WAS OBSERVED TO BE MELTED NEAR THE CONDUCTOR WIRE AREA. THERE WAS NO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A THERMAL DAMAGE OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT, 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 GATH... |
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 PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD TROUBLE WITH THE SUREFORM STAPLER 45 INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) TECHNIC... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING RECOGNITION/ ENGAGEMENT 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. THE FS... |
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 FAILED TO CLIP TWO TIMES. THE PROCEDURE WAS COMPLETED WI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MEDIUM -LARGE CLIP APPLIER(MLCA) INSTRUMENT FAILED TO CLIP TWO TIMES, 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 MLCA INSTRU... |
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 SACROCOLPOPEXY SURGICAL PROCEDURE, THE WRISTED NEEDLE DRIVER INSTRUMENT DID NOT ROTATE. A BACKUP INSTRUMENT WAS USED TO CONTINUE THE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INSTRUMENT DID NOT ROTATE, 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 WRISTED NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUN... |
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 SACROCOLPOPEXY SURGICAL PROCEDURE, THE WRISTED NEEDLE DRIVER INSTRUMENT DID NOT ROTATE. A BACKUP INSTRUMENT WAS USED TO CONTINUE THE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INSTRUMENT DID NOT ROTATE, 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 WRISTED NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUN... |
Brand Name:DAVINCI XIDevice Problem: Grounding MalfunctionPatient Problem: Burn(s)Event Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT EXPERIENCED A POTENTIAL BURN INJURY. THE ISSUE OCCURRED WHEN THE PATIENT WAS OBSERVED TO BE BURNED/HAVE SKIN ABRASION UNDER TH... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. REVIEW OF THE SYSTEM LOG WAS COMPLETED, AND NO RELATED... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING AN INCISIONAL HERNIA IPOM DA-VINCI ASSISTED SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED REPEATED ERRORS ON THE UNIVERSAL SURGICAL MANIPULATOR 3 (USM... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED ERRORS ON THE UNIVERSAL SURGICAL MANIPULATOR (USM 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 INVESTI... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, CUSTOMER WAS GETTING ERRORS ON THE ERBE GENERATOR. THE CLINICAL SALES REPRESENTATIVE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR MESSAGE ON 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. F... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WIRE WAS EXPOSED AT THE TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED ... | BASED ON THE CLAIM AGAINST THE PRODUCT NOTING THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WIRE WAS EXPOSED AT THE TIP, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A VSE INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE VSE WAS ANALYZED AND FOUND TO HA... |
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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON STATED THE INSTRUMENTS WERE NOT MOVING CORRECTLY, AND COULD NOT CONTROL THE ENDOSC... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INSTRUMENT WAS NOT MOVING CORRECTLY, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE FIELD SERVICE ENGINEER FOLLOWED UP WITH THE CUSTOMER WHO STATED THE ROBOT WAS FUNCTION... |
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 LADD'S PROCEDURE, A PIECE OF THE INSULATION TIP ON THE HARMONIC ACE INSTRUMENT FELL INTO THE PATIENT. THE SURGEON WAS DISSECTING THROUGH AN AD... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE HARMONIC ACE INSTRUMENT INSERT TIP FELL INTO 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 ACE INSTRUME... |
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 UROLOGY SURGICAL PROCEDURE, THE HEM-O-LOK CLIP APPLIER WAS NOT CLOSING AND CLAMPING CLIPS PROPERLY. THE PROCEDURE WAS COMPLETED AS PL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING CLIP APPLICATION 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 HEM-O-LOK CLIP APPLIER WAS ANALYZED AND THE COMPLAINT REGARDI... |
Brand Name:DA VINCI SPDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Burn(s); Skin InfectionEvent Description: ON (B)(6) 2023, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN ARCHIVES OF PLASTIC SURGERY ARTICLE TITLED, ¿SINGLE-PORT ROBOT-ASSISTED PROSTHETIC BREAST RECONSTRUCTIO... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE MENTIONED BURN AND POST-OPERATIVE INFECTION CANNOT BE DETERMINED. THERE WAS NO CLAIM AGAINST THE PRODUCT AND NO INDICATION OF A PRODUCT ISSUE, AND THUS THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT DID NOT MOVE INTUITIVELY. THE CUSTOMER RESEATED THE INS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE MOTION OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT, 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 EVALUA... |
Brand Name:ENDOWRISTDevice Problem: ArcingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA IPOM SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT ARCIN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ARCING, 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 REPO... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE CUSTOMER HAD TO DISABLE THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4. INTUITIVE SURGICAL, INC (ISI) TECH... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SEVERAL FAULTS ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4, 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 INVESTIG... |
Brand Name:ENDOWRIST;DAVINCI SIDevice Problem: Difficult to Open or Close; Material DeformationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE MEDIUM-LARGE CLIP APPLIER (ML... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE MEDIUM-LARGE CLIP APPLIER (MLCA) INSTRUMENT JAW WAS DEFORMED AND COULD NOT RELEASE THE CLIP PROPERLY, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PER... |
Brand Name:SUREFORMDevice Problem: Failure to FirePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SUREFORM STAPLER 45 INSTRUMENT HAD INCOMPLETE STAPLE LINE AND WAS NOT WORKING PROPERLY. THE PROCEDURE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INCOMPLETE STAPLE LINE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ISI HAS REQUESTED THE RELOAD INVOLVED WITH THIS COMPLAINT BE RETURNED BUT IT HAS NOT BEEN RECEIVED YET. THEREFORE, THE ROOT CAUSE OF THE ALLEGED CUSTOMER R... |
Brand Name:ENDOWRISTDevice Problem: Difficult or Delayed ActivationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED DURING A DA VINCI-ASSISTED HYSTERECTOMY-BENIGN SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT HAD DELAYED SEALING. THE PROCEDURE WAS ABORTED WITH... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE VESSEL SEALER EXTEND (VSE) INSTRUMENT HAD DELAYED SEALING, 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 VSE INSTRUMENT WAS ANA... |
Brand Name:NONEDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA UNILATERAL SURGICAL PROCEDURE. THE SURGEON ENCOUNTERED AN ISSUE WHERE ARMS 1 AND 3 WERE WORKING BACKWARDS. INTUITIVE SURGIC... | AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE TECHNICAL SERVICE ENGINEER (TSE) WALKED THE CUSTOMER THROUGH REMOVING THE ENDOSCOPE, ADJUSTING THE BASE 180 DEGREES, WIPING OUT GUIDED TOOL EXCHANGE, AND THEN REINSTALLING THE ENDOSCOPE... |
Brand Name:ENDOWRISTDevice Problem: Defective DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD THE TRANSMISSION CABLE EXPOSED. THE PROCEDURE WAS COMPLETED WITH NO REPORTE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING TRANSMISSION CABLE WAS EXPOSED, AN INVESTIGATION IS IN PROGRESS. 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 THE CUSTOMER REPORTED ISSUE. THI... |
Brand Name:ENDOWRISTDevice Problem: Material Integrity ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE SMALL BLACK TIP INSULATION CAME OFF OF THE PERMANENT CAUTERY HOOK (PCH). THE PROCEDURE WAS CO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SMALL BLACK TIP INSULATION CAME OFF OF THE PERMANENT CAUTERY HOOK (PCH), 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 PCH INST... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL CONDUIT SURGICAL PROCEDURE, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED THE ISI TECHNICAL SUPPORT ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE MASTER TOOL MANIPULATOR RIGHT (MTMR) DID NOT RESPOND, 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 INVESTI... |
Brand Name:DAVINCI XIDevice Problem: Energy Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ISOLATED NISSEN FUNDOPLICATION SURGICAL PROCEDURE, THE SYSTEM HAD LOW POWER ON THE VESSEL SEALER INSTRUMENT FOR E-100 AND INTEGRATED ELEC... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING LOW ENERGY WHEN VESSEL SEALER INSTRUMENT WAS BEING USED, 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 T... |
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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT WHILE REMOVING THE INSTRUME... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE HARMONIC ACE INSTRUMENT TIP BROKE OFF, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE INSTRUMENT HAS BEEN RETURNED BUT FAILURE ANALYSIS HAS NOT BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFOR... |
Brand Name:SUREFORMDevice Problem: Ejection Problem; Firing ProblemPatient Problem: Hemorrhage/Bleeding; Laceration(s)Event Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PULMONARY LOBECTOMY, THE PULMONARY ARTERY (PA) WAS INJURED WHILE STAPLING WITH A SUREFORM 45 CURVED-TIP INSTRUMENT AND WHITE SUREFORM 4... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE EXPOSED BLADE WHICH INJURED THE PULMONARY ARTERY (PA) CANNNOT BE DETERMINED. THE CUSTOMER CONFIRMED THE PRODUCT WAS DISCARDED AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. LOGS SHOW THAT... |
Brand Name:ENDOWRISTDevice Problem: Break; Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UMBILICAL HERNIA TRANSABDOMINAL PREPERITONEAL (TAPP) SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT BROKE. AT THE TIME THE EVENT... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. A REVIEW OF THE PROVIDED... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT EXHIBITED CLIPPING ISSUE. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT EXHIBITED CLIPPING ISSUE, AN INVESTIGATION IS IN PROGRESS. 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 SIDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PROCEDURE WAS CONVERTED TO OPEN BECAUSE THE DOCTOR COULD NOT FIND ANY ANATOMICAL PLANE IN ORDER TO IDENTIFY THE NEC... | 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 ADVERSE EVENT. BASED ON THE INVESTIGATION, THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE CONVERT TO OPEN. WHILE THERE WAS NO ALLEGATION THAT A MALFUNCTION OF 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 SURGICAL PROCEDURE, WHILE THE PROGRASP FORCEPS INSTRUMENT WAS LOADED AND DOCKED TO THE PATIENT, THE GRIP WOULD NOT FOLLOW COMMANDS OF T... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT PROGRASP FORCEPS INSTRUMENT WOULD NOT FOLLOW COMMANDS OF THE SURGEON, 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 DEV... |
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 SEGMENTAL PANCREATECTOMY SURGICAL PROCEDURE, THE FORCE TRIAD GENERATOR WAS UNABLE TO ACTIVATE THE BIPOLAR INSTRUMENT. THE CUSTOMER REC... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN AUTO-FIRING ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER STATED THAT THERE WERE TWO BIPOLAR INSTRUMENTS IN USE THAT WERE INSTALLED ON THE UNIVERSAL S... |
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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO CONTACT A TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED A BLACK LEFT EYE ON... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BLACK LEFT EYE ON THE SURGEON SIDE CONSOLES (SSC), AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPO... |
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 SURGICAL PROCEDURE, THE SINGLE-SITE WRISTED NEEDLE DRIVER INSTRUMENT DID NOT MOVE IN THE DESIRED DIRECTION. A BACKUP INSTRUMENT OF SA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SINGLE-SITE WRISTED NEEDLE DRIVER INSTRUMENT MOVED WITH UNINTUITIVE MOTION, 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 ... |
Brand Name:ENDOWRISTDevice Problem: Melted; Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP BLADE WAS MALFORMED AND DISFIGURED. THERE WAS NO REPORT OF PATIENT INVOLV... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING TIP 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 MCS INSTRUMENT WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS REPLICAT... |
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 SACROCOLPOPEXY SURGICAL PROCEDURE. THE WRISTED NEEDLE DRIVER INSTRUMENT DID NOT ROTATE. A BACKUP INSTRUMENT WAS USED TO CONTINUE THE... | BASED ON THE CLAIM AGAINST THE PRODUCT, BY THE CUSTOMER NOTING THE INSTRUMENT DID NOT ROTATE. 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 WRISTED NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOU... |
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 SACROCOLPOPEXY SURGICAL PROCEDURE, THE WRISTED NEEDLE DRIVER INSTRUMENT DID NOT ROTATE. A BACKUP INSTRUMENT WAS USED TO CONTINUE THE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INSTRUMENT DID NOT ROTATE, 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 WRISTED NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUN... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL GASTRECTOMY SURGICAL PROCEDURE, THE TIP OF THE MEDIUM-LARGE CLIP APPLIER (MLCA) SPUN AROUND ON ITS OWN. THE CUSTOMER USED A BACKU... | INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO PATIENT INJURY DUE TO THE EVENT. AT THE TIME OF EVENT, THE CLIP DID NOT BECOME DISLODGED FROM THE INSTRUMENT. THE CLIP DID NOT FALL INTO PATIENT'S ANATOMY. Manufacturer N... |
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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THAT THE HARMONIC ACE INSTRUMENT TIP WAS BROKEN. THE CUSTO... | BASED ON THE CLAIM AGAINST THE PRODUCT, BY THE CUSTOMER NOTING A BROKEN HARMONIC ACE INSTRUMENT TIP. 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 ACE INSTRUMENT WAS ANALYZED AND FOUND T... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device Component; Material Twisted/BentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER COMPLETING A DA VINCI-ASSISTED SURGICAL BILATERAL INGUINAL HERNIA, THE CADIERE FORCEPS INSTRUMENT WAS BENT AND COULD ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE ON THE CADIERE FORCEPS INSTRUMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE CADIERE FORCEPS INSTRUMENT WAS ANAL... |
Brand Name:DAVINCI XDevice Problem: Failure to SensePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BLADDER AUGMENTATION SURGICAL PROCEDURE, THE INSTRUMENT ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS NOT BEING RECOGNIZED. THE NURSE EXPLAIN... | 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 FIELD SERVICE ENGINEER FOUND UNIVERSAL S... |
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 PROSTATECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT JAWS WOULD NOT OPEN INSIDE THE PATIENT. IT WORKED OUTSIDE T... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING FAILURE TO UNCLAMP, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAIL... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA, THE USER WAS UNABLE TO ACTIVATE MONOPOLAR ENERGY. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT E... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN IESU 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. DURING FIELD EVALUATION... |
Brand Name:ENDOWRISTDevice Problem: Material Fragmentation; Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE TIP OF A FORCE BIPOLAR INSTRUMENT WAS DETACHED. THE PROCEDURE WA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE TIP OF A FORCE BIPOLAR INSTRUMENT WAS DETACHED, 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. FA... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSBRONCHIAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX. THE PROCEDURE SET-UP WAS NORMAL; THERE WERE NO ISSUES WITH THE ION SYSTEM. P... | 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 SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE. THIS EVENT IS BEING REPORTED DUE... |
Brand Name:DA VINCI SPDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Abdominal Pain; Hematuria; AscitesEvent Description: IT WAS REPORTED THAT THE PATIENT UNDERWENT DA VINCI-ASSISTED SP EXTRAPERITONEAL PROSTATECTOMY ON (B)(6) 2023 AS PART OF THE CGMH URO SP CLINICAL STUDY. THE PA... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE COMPLICATION(S) CANNOT BE DETERMINED. THERE WAS NO REPORT OF A MALFUNCTION OF A DA VINCI PRODUCT, THUS THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECE... |
Brand Name:DA VINCI XIDevice Problem: Physical Resistance/StickingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, ONE OF THE MASTER TOOL MANIPULATOR (MTM) WAS BEING STICKY ON ONE OF THE SURGEON SIDE CONS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING STICKY, 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 WAS UNABLE TO REPRODUC... |
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 SURGICAL PROCEDURE, UNIVERSAL SURGICAL MANIPULATOR (USM) 3 INSTRUMENT WAS NOT MOVING IN THE DIRECTION THE SURGEON WANTED. TECHNICAL SU... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNIVERSAL SURGICAL MANIPULATOR (USM) 3 INSTRUMENT MOTION 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 INVEST... |
Brand Name:ENDOWRISTDevice Problem: Material Integrity Problem; Unintended MovementPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA UNILATERAL SURGICAL PROCEDURE, THE TIP OF THE MEDIUM-LARGE CLIP APPLIER WOULD NOT ROTATE PROPERL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE TIP WOULD NOT ROTATE PROPERLY, 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 GATHERE... |
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 HYSTERECTOMY- BENIGN PROCEDURE, THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SPINNING AROUND ON ITS OWN, AN INVESTIGATION IS IN PROGRESS. 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 CONTRIBUTION OF THE DEVICE TO THE ... |
Brand Name:DA VINCI SPDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Failure to AnastomoseEvent Description: IT WAS REPORTED THAT THE PATIENT UNDERWENT A DA VINCI-ASSISTED LOWER ANTERIOR RESECTION (LAR) PROCEDURE ON (B)(6) 2023 AS PART OF THE SP COLORECTAL IDE STUDY. THE PATIENT ... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE ANASTOMOTIC LEAKAGE CANNOT BE DETERMINED. THERE WAS NO REPORT OF A DA VINCI PRODUCT MALFUNCTION AND THUS THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A SYSTE... |
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 VENTRAL HERNIA REPAIR SURGICAL PROCEDURE, A PROGRASP FORCEPS INSTRUMENT BROKE INSIDE OF THE PATIENT. THE CUSTOMER INDICATED THAT THEY WER... | THE PROGRASP FORCEPS INSTRUMENT WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS EVENT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE PROGRASP... |
Brand Name:DAVINCI XIDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT JAW BROKE AND A PIECE FELL INSIDE THE PATIENT. PRIOR TO CALLING IN, ... | THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT I... |
Brand Name:DAVINCI XIDevice Problem: Energy Output ProblemPatient 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 WORKING PROPERLY. THE TECHNICAL SUPPORT ENGINEER (TSE) ASSISTED CLINICAL SALES R... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING E-100 WENT DOWN 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. FSE IDENTIFIED THAT T... |
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 WAS STIFF AND DID NOT MOVE IN THE INTENDED DIRECTION, 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... |
Brand Name:ENDOWRISTDevice Problem: Unintended MovementPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE. THE MONOPOLAR CURVED SCISSORS INSTRUMENT MOVED UNINTUITIVELY. THE SURGEON WANTED TO CLOSE THE SCISSORS AND THEY CHANGED... | BASED ON THE CLAIM BY THE CUSTOMER NOTING, NON-INTUITIVE MOTION WITH THE MONOPOLAR CURVED SCISSORS. AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA HAS BEEN ISSUED, REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DE... |
Brand Name:ENDOWRIST;DAVINCI SIDevice Problem: ArcingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED THORACIC SURGICAL PROCEDURE. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT SPARKED, WHILE ENERGY WAS BEING APPLIED. THE CABLE CONNECTION SLOT ALSO ... | BASED ON THE CLAIM AGAINST THE PRODUCT, BY THE CUSTOMER NOTING THE MARYLAND BIPOLAR FORCEPS INSTRUMENT SPARKED WHILE ENERGY WAS BEING APPLIED. 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 ... |
Brand Name:ENDOWRISTDevice Problem: Break; Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL HYSTERECTOMY- BENIGN PROCEDURE, THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (T... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION COULD NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT ¿ROBOT FAILED TO RECOGNIZE¿. THE INSTRUMENT WAS PLACED AND DRIVEN... |
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 JAWS WERE NOT CLOSING ON THE MEDIUM-LARGE CLIP APPLIER. THE PROCEDURE WAS COMPLETED WITH NO R... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE JAWS WERE NOT CLOSING, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE BOTH GRIPS BENT. AS A RESULT, THE CLIP COULD NOT BE PROPERLY LOADED ON THE GRIPS.... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of Device; MeltedPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INSULATING SHEATH WAS MELTED. THE PROCEDURE ... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT ¿MARYLAND BIPOLAR FORCEPS (MBF) WAS MELTED¿. THE MBF INSTRUMENT WAS ANALYZE... |
Brand Name:ENDOWRIST;DAVINCI SIDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WIRE WAS SNAPPED. THE PROCEDURE WA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SNAPPED, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA HAS BEEN ISSUED REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF TH... |
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 FAILED TO ENGAGE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT COULD NOT CLOSE A CLIP, 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 DEVICE RETU... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SLEEVE GASTRECTOMY TO ROUX-EN-Y REVISION, THERE WAS A TISSUE PUSH EVENT. THROUGH FOLLOW UP WITH THE SURGEON, THE FOLLOWING INFORMATION WAS CONFIRMED OR OB... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE TISSUE PUSHOUT EVENT CANNOT BE DETERMINED. THE BLUE SUREFORM 60 RELOAD WAS CONFIRMED TO BE DISCARDED THUS UNAVAILABLE FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. LOGS SHOW THE SUREFORM STAPLER USED IN THE EVENT WAS ... |
Brand Name:NONEDevice 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 ENDOSCOPE HAD NON-COHERENT IMAGE, GENERATING A NON-INTUITIVE MOTION. THE CUSTOMER WAS USING 3... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A NON-INTUITIVE MOTION OF THE ENDOSCOPE PLUS, 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 DEVICE RETURNED. ISI HAS NOT RECEIV... |
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 BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) HIGH RESOLUTION STEREO VIEWER (HRSV) DISPLAY WAS LOST. THE CUSTOM... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING LOSS OF VISION ON THE RIGHT SSC HRSV DISPLAY, 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... |
Brand Name:DA VINCI ENERGYDevice Problem: Failure to Deliver EnergyPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THERE WAS A MESSAGE FOR THE SYNCHROSEAL INSTRUMENT S/N (B)(4), "INSPECT JAWS FOR POSS... | BASED ON THE CLAIM ALLEGING THAT THE SYNCHROSEAL HAD AN INCOMPLETE ACTIVATION CYCLE BY THE CUSTOMER, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE SYNCHROSEAL INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE D... |
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 PROCEDURE THE CUSTOMER HAD ISSUES WITH THE MEDIUM-LARGE CLIP APPLIER NOT HOLDING CLIPS AND WAS NOT GIVING THE INSTRUM... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ISSUES WITH THE MEDIUM-LARGE CLIP APPLIER NOT HOLDING CLIPS AND NOT GIVING THE INSTRUMENT USAGE NUMBER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAI... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of Device; MeltedPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INSULATING SHEATH WAS MELTED. THE PROCEDURE ... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE CHARRING AND LOCALIZED MELTING AT THE GRIP BASE BETWEEN THE GRIPS. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. AN ADDITIONAL OBSERVATION RELATED TO 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 SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT DID NOT ROTATE CORRECTLY AND MOVED WITH NON-INTUITIVE MOTION. THE PROCEDURE WAS COMPLE... | 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 FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE INS... |
Brand Name:ENDOWRISTDevice Problem: Unintended System Motion; 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 PROGRASP FORCEPS INSTRUMENT "GOT STUCK." THE INITIAL REPORT INDICATED THAT THE ISSU... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER THAT THE PROGRASP FORCEPS INSTRUMENT GOT STUCK AND NON-INTUITIVE MOVEMENT, THE INFORMATION GATHERED INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE REPORTED FAILURE AGAINST THE INSTRUMENT INVOLVED WITH THE COMPLAINT WAS NOT CONFIRMED BY... |
Brand Name:DAVINCI XIDevice Problem: Positioning FailurePatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY PROCEDURE, THE PATIENT EXPERIENCED A CONVERSION TO LAPAROSCOPY. THE ISSUE OCCURRED WHEN THE SURGEON WAS UNABLE TO CON... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. HOWEVER, ACCORDING TO THE FIELD SERVICE ENGINEER, HE BELIEVES THE COMPLICATION WAS CAUSED BY THE LEFT MTM MISSING ITS GRIP MAGNET. THE DEVICE INVOLVED WITH THIS EVENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALU... |
Brand Name:ENDOWRISTDevice Problem: Patient Device Interaction ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY PROCEDURE, BLEEDING CONTROL WAS DELAYED. THE ISSUE OCCURRED WHEN THE 8MM FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUM... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT FAILED MECHANICAL ENGAGEMENT WHEN PLACED ON THE SYSTEM. THE INSTRUMENT INPUTS FAILED TO ENGAGE WITH THE STERILE ADAPT... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WOULD NOT CLAMP TO PLACE CLIP. THE SITE SWAPPED TO A BACKUP INSTRUME... | INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS OBSERVED. THE INCIDENT WITH THE LARGE HEM-O-LOK CLIP APPLIER WAS RELATED TO A C... |
Brand Name:DAVINCI XIDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SURGEON FELT THAT UNIVERSAL SIDE MANIPULATOR (USM) ARM 1 MOVEMENT WAS "JERKY". NO OTHER ISSUE WAS OBSERVED. THE PROCE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ALLEGED NON-INTUITIVE MOVEMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER SITE AND THE ISI CSR TO FURTHER INVESTIGATE THE REPORTED EV... |
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, NON-RECOVERABLE FAULT 319 OCCURRED AFTER DRAPING THE SYSTEM. ANOTHER VISION SIDE CART (VSC) WAS USED TO PROCE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT A NON-RECOVERABLE FAULT 319 OCCURRED AFTER DRAPING THE SYSTEM, 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 INVESTIGAT... |
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, A PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND HOSPITALIZATION. THE SIZE OF THE BIOPSIED LESION WAS 9 M... | 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. THE PHYSICIAN REPORTED THAT THE COMBINATION OF SEVERE EMPHYSEMA, ENDOBRONCHIAL VALVES ON THE LEFT SIDE, THE LESION ... |
Brand Name:DA VINCIDevice Problem: Power ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED DURING A DA VINCI-ASSISTED PROCEDURE, THE XI SYSTEM HAD A NON-RECOVERABLE FAULT WHILE CLAMPING THE RENAL VEIN. THE CUSTOMER WAS UNABLE TO MOVE THE ARM BACK BECAUSE THE INSTRUMENT ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE POWER ISSUE, 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. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PROD... |
Brand Name:DA VINCI SPDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Unspecified Blood or Lymphatic problemEvent Description: IT WAS REPORTED THAT THE PATIENT UNDERWENT DA-VINCI ASSISTED LOBECTOMY ON (B)(6) 2023 AS PART OF THE CGMH SP CLINICAL STUDY. ON (B)(6) 2023, THE PATIENT D... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CHYLOTHORAX CANNOT BE DETERMINED. THERE WAS NO CLAIM AGAINST THE PRODUCT AND NO INDICATION OF A PRODUCT ISSUE, AND THUS THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RE... |
Brand Name:DA VINCI XIDevice Problem: Physical Resistance/StickingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY TRANSTHORACIC - CHEST ANASTOMOSIS SURGICAL PROCEDURE, ONE OF THE MASTER TOOL MANIPULATORS (MTM) WAS BEING STICKY ON... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ONE OF THE MASTER TOOL MANIPULATOR (MTM) WAS BEING STICKY 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 CU... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY-BENIGN SURGICAL PROCEDURE, THE 0-DEGREE ENDOSCOPE ROTATED 180-DEGREE ON ITS OWN. THE CUSTOMER USED A BACKUP ENDOSCOPE. THE P... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE MOTION WITH THE 0 DEGREE ENDOSCOPE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL INC. (ISI) HAS RECEIVED THE 0 DEGREE ENDOSCOPE; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATIO... |
Brand Name:DAVINCI XIDevice Problem: Power ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE OPERATION ROOM (OR) STAFF CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT "PATIENT CART RUNNING ON BATTERY" MESS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SYSTEM POWER SUPPLY 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 S... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN-HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT DID NOT OPERATE AS EXPECTED AND FAILED TO CLOSE WHICH LED TO A TEAR OF ... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE AND OPERATIVE COMPLICATION CANNOT BE DETERMINED. ISI HAS NOT RECEIVED THE INSTRUMENT INVOLVED WITH THIS EVENT FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG ... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, THE LONG BIPOLAR GRASPER INSTRUMENT HAD A BLACK CABLE TORN OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTU... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE BLACK CABLE TORN OFF, 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 DE... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: Hemorrhage/Bleeding; Laceration(s)Event Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY WITH RIGHT UPPER LOBE RESECTION; THE SURGEON USED THE MEDIUM-LARGE CLIP APPLIER TO CLIP A BRANCH OF THE PULMONARY VEIN. ... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THE FAILURE ANALYSIS DID NOT DETECT ANY ISSUES WITH THE INSTRUMENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. INTUITIVE HAS RECEIVED THE PART ASSOCIATED WITH THIS COMPLAINT AND COMPLET... |
Brand Name:ENDOWRISTDevice Problem: CrackPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE. THE FORCE BIPOLAR INSTRUMENT WRIST MISALIGNED DURING THE PROCEDURE. THE INSTRUMENT BECAME STUCK IN THE TROCAR, AND THE CUSTOMER HAD T... | BASED ON THE CLAIM AGAINST THE PRODUCT, BY THE CUSTOMER NOTING INSTRUMENT WRIST MISALIGNED AND STUCK IN 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 FORCE BIPOLAR INSTRUMENT WAS ANALYZ... |
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 CABLE OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS BROKEN. THE CUSTOMER REPLACED THE INSTRUMENT TO CONTINUE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN CABLE OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTO... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT ARM 2 LOCKED UP W... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING FAULT ON ARM 2 AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCH ON SITE TO INVESTIGATE THE REPORTED PROBLEM. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISS... |
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 SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERRORS C-34, M-11 AND C-30 ON VIO DV INTEGRATED 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 CUSTOMER... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT ERBE GENERATOR FAULTED. THE ISSUE ALSO OCCURRED PRIOR TO THE START OF THE PROCEDURE AS WELL. THE INTUITIVE SURGICAL INC.... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE ERBE GENERATOR FAULTED, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) REPLACED THE ERBE GENERATOR TO RESOLVE THE REPORTED ISSUE. AN RMA WAS ISSUED TO EVAL... |
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, THERE WAS A NON-RECOVERABLE FAULT ON THE E-100 GENERATOR. THE CUSTOMER TRIED TO POWER CY... | BASED ON THE CLAIM AGAINST THE PRODUCT, BY THE CUSTOMER NOTING, THERE WAS A NON-RECOVERABLE FAULT ON THE E-100 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 INVESTIGAT... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HEM-O-LOK CLIP APPLIER TIP WOULD NOT COME TOGETHER. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, I... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE TIP OF THE HEM-O-LOK CLIP APPLIER WOULD NOT COME TOGETHER, 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 INFO... |
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 CLIP APPLIER INSTRUMENT WAS UNABLE TO BE USED FOR THE SURGICAL TASK. A BACKUP INSTRUMENT OF SAME KIND ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INSTRUMENT WAS UNABLE TO BE USED. AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED, AND ... |
Brand Name:DAVINCI XIDevice Problem: Insufficient InformationPatient Problem: Burn(s); Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNSPECIFIED PROCEDURE, THE PATIENT EXPERIENCED PORT BURNS. THE ISSUE OCCURRED DURING THE USE OF A THIRD-PARTY STORZ MONOPOLAR LAPAROSCOPIC INS... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. IT IS UNCLEAR AS TO WHETHER THE THIRD-PARTY STORZ MONOPOLAR LAPAROSCOPIC INSTRUMENT OR THE DA VINCI VISION SIDE CART THAT THE COMPLAINT IS REPORTED UNDER CONTRIBUTED TO THE PORT BURNS. THE ANNEX CODES REFLECT AN ISI... |
Brand Name:DAVINCI SIDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OROPHARYNGECTOMY SURGICAL PROCEDURE, THE ARM 2 MOVED UNEXPECTEDLY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN UNEXPECTED MOTION ON ARM2, 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 WASN... |
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 TRANSTHORACIC ESOPHAGECTOMY WITH CHEST ANASTOMOSIS SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT... | 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:DA VINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT AT THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, POST-ANESTHESIA AND PORT PLACEMENT, THE SURGICAL TEAM HAD A NON-RECOVERABLE ERROR 86. PRIOR TO CALLING, THE CUSTOME... | ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE REDUNDANT POWER TRAY ASSEMBLY WAS ANALYZED AND THE REPORTED FAILURE OF ERROR 86 WAS REPLICATED. THIS UNIT WAS INSTALLED INTO THE TEST SYSTEM, AND IT FAILED WITH ERROR 86 DUE TO 10 POWER CYCLES. BOTH POWER SUPPLIES WERE GOOD... |
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 UROLOGY SURGICAL PROCEDURE, THE CUSTOMER CALLED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND STATED THAT THE UNIVERSAL ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNIVERSAL SURGICAL MANIPULATOR 3 (USM) WAS NOT FUNCTIONAL, 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... |
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 LABELED THAT IT WAS BROKEN WITH NO REASON. THE PROCEDURE WAS COMPLETED WITH NO REPORTED ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INSTRUMENT BEING 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 BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOU... |
Brand Name:DAVINCI SIDevice Problem: Energy Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL ESOPHAGECTOMY TRANSTHORACIC WITH CHEST ANASTOMOSIS PROCEDURE, THE CUSTOMER WAS FACING AN ISSUE WITH THE VESSEL SEALER. THE CUSTO... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT CONTROL BOX (IBC) ASSEMBLY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT ¿VESSEL SEALER NOT WORKING¿. THE PRINTED CIRCUIT ASSEMBLY (PCA) TECHNICIAN WAS ABLE TO... |
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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, A VESSEL SEALER EXTEND INSTRUMENT WOULD GET HOT, BUT WON'T SEAL. THE CUSTOMER USED A BACK-UP IN... | 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 THE VESSEL SEALER EXTEND INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT FAILED ELECTRICAL CONTINUITY TEST. THE GRIP TIP WITHOUT THE CER... |
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 LARGE HEM- O- LOK- CLIP APPLIER INSTRUMENT WOULD NOT APPLY THE CLIPS. THE PROCEDURE WAS COMPL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING WOULD NOT APPLY THE CLIPS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE CLIP APPLIER INSTRUMENT WAS ANALYZED AND THE FAILURE ANALYSIS INVESTIGATION CONFIRMED/REPLICATED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FO... |
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