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Brand Name:SUREFORMDevice Problem: Failure to Form Staple; Failure to CutPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION PROCEDURE, THE CURVED-TIP SUREFORM 45 STAPLER INSTRUMENT FIRED AN UNSPECIFIED COLORED RELOAD AND THE TARGET TISS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A TISSUE PUSHOUT EVENT, AN INVESTIGATION IS IN PROGRESS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE STAPLER OR THE RELOAD IN ORDER TO PER... |
Brand Name:SUREFORMDevice Problem: MisfirePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT DID NOT DEPLOY STAPLES ON THE FIRST PORTION OF THE TARGET TISSUE DURING THE FIRST FIRE. THE SURG... | INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SUSPECTED SUREFORM 60 STAPLER INSTRUMENT AND WHITE RELOAD WERE NO LONGER AVAILABLE. THE SUREFORM 60 STAPLER INSTRUMENT WAS INSPECTED PRIOR TO USE, WITH NO ISSUES FOUND. A WHITE RELOAD WAS INVOLVED... |
Brand Name:DAVINCI XIDevice Problem: Failure to Deliver Energy; No Device OutputPatient Problem: Full thickness (Third Degree) BurnEvent Description: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY, THE SURGEON WAS UNABLE TO FIRE MONOPOLAR ENERGY FROM THE INTEGRATED ELECTROSURGICAL GENERAT... | BASED ON THE CURRENT INFORMATION RECEIVED, THE ROOT CAUSE OF THE CUSTOMER REPORTED EVENT CANNOT BE DETERMINED. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED COMPLAINT. THE FSE TESTED THE ERBE IESU AND COULD NOT REPROD... |
Brand Name:NONEDevice Problem: Defective ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE PLUS 0 DEGREE WAS OBSERVED WITH MECHANICAL DAMAGE. THE PROCEDURE WAS COMPLETED WITH THE SAME ENDOSCOPE WITH NO ... | IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE PLUS 0 DEGREE WAS OBSERVED WITH MECHANICAL DAMAGE. BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ENDOSCOPE DAMAGE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI... |
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 GYNECOLOGICAL SURGICAL PROCEDURE THAT RIGHT GIMBAL ON THE RIGHT MASTER TOOL MANIPULATOR (MTM) WAS HAVING DIFFICULTY OPENING AND CL... | IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE RIGHT MASTER TOOL MANIPULATOR (MTM) WAS DIFFICULT TO OPEN/CLOSE AND WOULD BECOME STUCK. THE PROCEDURE WAS COMPLETED WITH A NEW SURGEON SIDE CONSOLE (SSC). THERE WERE NO REPORTS OF PATIENT INJURY. BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CU... |
Brand Name:DAVINCI XIDevice Problem: Output Problem; No Apparent Adverse EventPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE THAT THERE WAS A RECOVERABLE FAULT ON THE LEFT-HAND CONTROLLER OF THE SURGE... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. BASED ON THE FIELD EVALUATION, THE FSE REPLACED THE LEFT MASTER TOOL MANIPULATOR (MTML) 2 TO RESOLVE THE ISSUE. THE SYSTEM HAS BEEN TESTED AND IS OPERATING WITHIN ISI SPECIFI... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING THE START OF A DA VINCI-ASSISTED HYSTERECTOMY BENIGN SURGICAL PROCEDURE, THEY HAD COUPLE RECOVERABLE FAULTS. TECHNICAL SERVICE ENGINEER (TSE) REVIEWE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING RECOVERABLE FAULTS, 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 WENT ON SITE A... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED HYSTERECTOMY BENIGN SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SERVICE ENGINEER (TSE) AS THEY WERE HAVING ISSUES WITH MULTIPLE SCOP... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING MULTIPLE SCOPE ISSUES, 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 WENT ON... |
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 SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT FAILED TO APPLY THE CLIPS. A BACKUP INSTRUMENT O... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING CLIPPING FAILURE, AN INVESTIGATION IS IN PROGRESS. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE R... |
Brand Name:DAVINCI XIDevice Problem: Blocked ConnectionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING DA VINCI ASSISTED APPENDECTOMY SURGICAL PROCEDURE, BLUE FIBER OF PSC BROKE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING CABLE BREAKAGE ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. AN ISI FIELD SERVICE ENGINEER (FSE)/ FIELD EN... |
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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE SURGEON CALLED TO REPORT THAT ERROR 25770 OCCURRED AND THE ENDOSCOPE WAS NOT MOVING. ... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. DUE TO REPEATED SYSTEM ERROR 25770, THE FSE REPLACED THE REMOTE ARM CONTROLLER (RAC1) MASTER TOOL MANIPULATOR LEFT (MTML) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERI... |
Brand Name:DAVINCI XIDevice Problem: No Apparent Adverse Event; Unexpected ShutdownPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SIDE CART (PSC) SHUT DOWN. THEY RESTARTED THE SYSTEM, AND THE ISSUE WAS CLEARED.... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE REPLACED THE SYSTEM POWER MANAGER (SPM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS ... |
Brand Name:ENDOWRISTDevice Problem: Structural ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HEM-O-LOCKS CLIP APPLIER INSTRUMENT DID NOT STAY IN POSITION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. FO... | BASED ON THE CLAIM AGAINST THE PRODUCT, 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. AS OF THE DATE OF THIS REPORT, THE INSTRUMENT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS BEING GA... |
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 HYSTERECTOMY SURGICAL PROCEDURE, A PIECE OF THE HARMONIC ACE INSTRUMENT BROKE OFF DURING USE. THE SURGEON HAD JUST FINISHED ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A PIECE OF THE HARMONIC ACE INSTRUMENT BROKE OFF DURING USE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE WAS ANALY... |
Brand Name:ENDOWRISTDevice Problem: Intermittent Energy OutputPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE VESSEL SEALER EXTEND INSTRUMENT WOULD NOT SEAL CORRECTLY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. T... | THE VESSEL SEALER EXTEND (VSE) INSTRUMENT HAS BEEN RETURNED AND THE PRODUCT EVALUATION HAS BEEN COMPLETED. FAILURE ANALYSIS WAS NOT ABLE TO REPRODUCE THE CUSTOMER REPORTED COMPLAINT. BASED ON LOG REVIEW AND DURING IN-HOUSE TESTING, NO FAILURES WERE OBSERVED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. 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 GENERAL SURGICAL PROCEDURE, THE 8MM FENESTRATED BIPOLAR FORCEPS WAS NOT FOLLOWING THE MOVEMENTS OF THE SURGEON AT THE SURGEON SIDE CONS... | A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED AND INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED TO HAVE THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT BE RETURNED FOR EVALUATION; HOWEVER, THE INSTRUMENT HAS NOT YET BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FA... |
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 VESSEL SEALER EXTEND (VSE) INSTRUMENT DID NOT MOVE PROPERLY. THE INSTRUMENT MOVED IN THE OP... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT ARM DRAPE THAT WAS USED WITH THE VESSEL SEALER EXTEND INSTRUMENT. FAILURE ANALYSIS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. NO PHYSICAL DAMAGE OBSERVED ON THE DRAPE DURING VISUAL INSPECTION. THE DRAPE WAS TESTED WITH AN IN-HOUSE INSTRUMENT. TH... |
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 PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE HEM-O-LOK CLIP APPLIER INSTRUMENT DID NOT ROTATE PROPERLY TO APPLY T... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE HEM-O-LOK CLIP APPLIER INSTRUMENT DID NOT ROTATE PROPERLY TO APPLY THE CLIPS 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 LARG... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT DID NOT RESPOND PROPERLY TO CONTROLS. THE PROCEDURE WAS COMPLETED W... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING DID NOT RESPOND PROPERLY TO CONTROLS, 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 PROGRASP FORCEPS WAS ANALYZED AND THE COMPLAINT... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY MALIGNANT SURGICAL PROCEDURE, THE LARGE NEEDLE DRIVER INSTRUMENT IMPROPERLY RESPONDED TO COMMANDS. THE PROCEDURE WAS COMPL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING IMPROPERLY RESPONDS TO COMMANDS, 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 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 MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS IMPROPERLY RESPONDED TO COMMANDS. THE PROCEDURE WAS COMPLETE... | ON 06-FEB-2023, INTUITIVE SURGICAL, INC. REVIEWED THE RECORD AND CONFIRMED THAT NO INSTRUMENT IS RETURNING UNDER THIS RECORD. ISI'S REVIEW OF THE SITE¿S COMPLAINT HISTORY REVEALED THAT THE REPORTABLE EVENT INCLUDING THE FAILURE ANALYSIS ON THE REFERENCED INSTRUMENT HAS BEEN SUBMITTED UNDER PATIENT IDENTIFIER (B)(6), WH... |
Brand Name:SINGLE-SITEDevice Problem: Detachment of Device or Device Component; Difficult to Open or ClosePatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER MANIPULATED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT BUT W... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE CLIPPING FAILURE AND THAT THE CLIP FELL INTO THE PATIENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS AND THE MEDIUM-LARGE CLIP AP... |
Brand Name:DAVINCI XIDevice Problem: Electro-Static DischargePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THE SURGEON FELT ZAPPING AND BURNING ON THE SIDE OF HIS FOOT WHEN PRESSING ON THE RIGHT BLUE MONOP... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ELECTRICAL DISCHARGE AT THE SURGEON SIDE CONSOLE (SSC) MONOPOLAR FOOT PEDAL, 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 F... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR INSTRUMENT HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO R... | 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 SMALL GRASPING RETRACTOR INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAV... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI- ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD BROKEN CABLES. A BACKUP INSTRUMENT OF THE SAME KIN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKEN CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN DI... |
Brand Name:ENDOWRISTDevice Problem: Material Integrity ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAW OF THE PROGRASP FORCEPS INSTRUMENT WAS DETACHED FROM THE SHAFT AND COULD BE BROKEN WHEN REMOVING FROM THE... | IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAW OF THE PROGRASP FORCEPS INSTRUMENT WAS DETACHED FROM THE SHAFT AND COULD BE BROKEN WHEN REMOVING FROM THE CANNULA. BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKEN MAIN TUBE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE C... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI- ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD BROKEN CABLES RIGHT AFTER STARTING THE 10CM MYOMA ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKEN CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN DI... |
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 8MM FENESTRATED BIPOLAR FORCEPS GRASPING TIP WAS BROKEN ON ONE SIDE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH N... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF INSTRUMENT GRIPS-TIPS/BROKEN TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKE... |
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 FENESTRATED BIPOLAR FORCEPS HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL,... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKEN CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE D... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS IMPROPERLY RESPONDED TO COMMANDS. THE PROCEDURE WAS COMPLETED W... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING IMPROPERLY RESPONDS TO COMMANDS, 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,... |
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 MITRAL VALVE REPAIR SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED A NON-REC... | ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE REMOTE ARM CONTROLLER (RAC) WAS ANALYZED HOWEVER FAILURE ANALYSIS COULD NOT REPRODUCE THE ISSUE FOR NON-RECOVERABLE ERROR 22553. THE RAC WAS INSTALLED INTO PCA TEST SYSTEM AND RAN FOR 10 MINUTES, SINCE CYCLE, 60 POWER CYCLE... |
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 APPENDECTOMY SURGICAL PROCEDURE, INTEGRATED ELECTROSURGICAL UNIT (IESU) U-02 ERROR WAS DISPLAYED. THE INTUITIVE SURGICAL, INC. (I... | THE CATALOG NUMBER IDENTIFIED HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE LIFESTENT 5F VASCULAR STENT THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE LIFESTENT 5F VASCULAR STENT ARE IDENTIFIED. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFO... |
Brand Name:DA VINCI SPDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, A 'LEFT HAND CONTROL SWITCHES HAVE BEEN DISABLED BY SYSTEM' MESSAGE APPEARED. THE SURGEON DECIDED TO CO... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. DURING FIELD EVALUATION, THE FSE CONDUCTED AN INSPECTION BUT COULD NOT REPRODUCE THE ISSUE. THE LEFT MASTER TOOL MANIPULATOR (MTML) OPTO SWITCH WAS INTERMITTENTLY NOT AVAILAB... |
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 CYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER WAS FACING REPEATED RECOVERABLE FAULT 32099. AN INTUITIVE SURGICAL, INC. (ISI... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT. IN REMOTEFE, FA CONFIRMED 32099 ERRORS INDICATING A FAULT WITH THE AXES CONTROLLER, MOTOR (ACM) PRINTED CIRCUIT ASSEMBLY (PCA).... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE MEDIUM-LARGE CLIP APPLIER HAD LOOSE CABLE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE MED... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING LOOSE 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 MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A LO... |
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 PROCEDURE, 8MM MEDIUM-LARGE CLIP APPLIER CLIP WOULD NOT CLAMP PROPERLY ONTO DUCTS. DOCTOR AND TECH NOTICE THE TIP OF ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INSTRUMENT WOULD NOT CLAMP 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 MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ANA... |
Brand Name:ENDOWRISTDevice Problem: Material Fragmentation; Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE THE 8MM FENESTRATED BIPOLAR FORCEPS BROKE AT DISTA... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE 8MM FBF INSTRUMENT WAS ANALYZED, AND FAILURE ANALYSIS (FA) FOUND THE PRIMARY FAILURE OF BROKEN MAIN TUBE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE IN... |
Brand Name:ENDOWRISTDevice Problem: Physical Resistance/StickingPatient Problem: Hemorrhage/Bleeding; Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS STICKING TO TISSUE. THIS RESULTED IN THE SURGEON RIPPING ... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION HAS BEEN DEEMED TO BE PRODUCT RELATED. INTUITIVE SURGICAL INC. (ISI) REQUESTED THE CUSTOMER TO RETURN THE VESSEL SEALER EXTEND (VSE) INSTRUMENT USED DURING THIS PROCEDURE, BUT THE PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW-UP MDR WILL BE SUBMITTED I... |
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 MYOMECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER FELL OFF AND THE SURGE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MCS TIP COVER FELL OFF DURING THE PROCEDURE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. SYSTEM LOGS WERE REVIEWED, AND NO DEGRADED PERFORMANCE WAS NOTICED WITH THE SY... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, THERE WERE REPEATED RECOVERABLE FAULTS ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE CUST... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE CONFIRMED SEVERAL UNIVERSAL SURGICAL MANIPULATOR (USM) ERRORS IN THE LOGS AND REPLACED THE USM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT REGARDI... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER DA VINCI ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS WAS FOUND TO HAVE THERMAL DAMAGE ON PLASTIC ATTACHED TO THE INSTRUMENT. THE PRO... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE CHARRING AND LOCALIZED... |
Brand Name:DAVINCI XIDevice Problem: Unintended System MotionPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE VESSEL SMALL THORACOTOMY PROCEDURE, THE INSTRUMENT INSTALLED ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 UNEXPECTEDLY MOVED/TURNED WITHOUT SU... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION HAS BEEN DEEMED TO BE PRODUCT RELATED. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE FOUND ERROR 23007 AND REPLACED UNIVERSAL SURGICAL MAN... |
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 GENERAL SURGICAL PROCEDURE, ARM 2 WAS HAVING RECOVERABLE FAULTS. PRIOR TO THE CALLING, THE CUSTOMER RECOVERED THE FAULT. TECHNICA... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE CONFIRMED THE REPORTED ISSUE AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE USM... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE STAFF ENCOUNTERED MULTIPLE REPEATED RECOVERABLE FAULTS ON UNIVERSAL SUR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING MULTIPLE REPEATED RECOVERABLE FAULTS ON UNIVERSAL SURGICAL MANIPULATOR (USM) 3 WHERE SITE HAD TO DISABLE THE ARM, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS... |
Brand Name:DAVINCI XDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Hemorrhage/Bleeding; Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL PANCREATECTOMY PROCEDURE, THE SPLENIC VEIN WAS PARTIALLY DISRUPTED WHILE THE SURGEON WAS DISS... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION OR REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS NOT PERFORMED FOR TH... |
Brand Name:DA VINCI XIDevice Problem: Failure to Deliver EnergyPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, IT WAS IMPOSSIBLE TO COAGULATE WITH MONOPOLAR INSTRUMENT. PRIOR TO CALLING TECH SUPPORT, SIT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A COAGULATION, 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 FOUND HARD C-34 ERR... |
Brand Name:IONDevice Problem: Unintended System MotionPatient Problem: Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE CATHETER TURNED INWARD ACCORDING TO THE INITIAL REPORTER. THE LESION BIOPSIED WAS IN THE RIGHT LOWER LOBE BY THE DIAPHRAGM. THE PHYSICIAN... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE INSPECTED THE ION SYSTEM AND WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE. THE SYSTEM WAS INSPECTED IN ACCORDANCE WITH ISI PROCEDURES AND 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 SIGMOID COLECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE REPEATED ER... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VIDEO PROCESSOR (VP) UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS WAS TO REPRODUCE/CONFIRM THE REPORTED COMPLAINT. THE VP WAS INSTALLED INTO THE TEST EQUIPMENT FOR FUNCTIONAL TEST. DURING BOOTING PROCESS, THE SYSTEM HA... |
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 30-DEGREE ENDOSCOPE WAS TURNING/FLIPPING ON ITS OWN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITI... | THE 30-DEGREE ENDOSCOPE INSTRUMENT INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS INVESTIGATION HAS YET TO BE COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED POST ENGINEERING EVALUATION OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOL... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL GASTRIC BYPASS SURGICAL PROCEDURE, STAPLES WERE MISSING FROM THE STAPLE LINE AFTER A WHITE SUREFORM 60 RELOAD WAS FIRED WITH A SUREFORM 60 STAPLER... | BASED ON THE INFORMATION PROVIDED, IT IS INDETERMINABLE AS TO WHAT CAUSED OR CONTRIBUTED TO THE STAPLING FIRING ISSUE. THE SITE CONFIRMED THAT THE WHITE SUREFORM 60 RELOAD ASSOCIATED WITH THIS COMPLAINT HAS BEEN DISCARDED AND IS UNAVAILABLE FOR FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFOR... |
Brand Name:DAVINCI XIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Cardiac ArrestEvent Description: IT WAS REPORTED THAT APPROXIMATELY 90 MINUTES INTO A DA VINCI-ASSISTED LOWER ANTERIOR RESECTION (LAR) AND ENDOMETRIOSIS RESECTION PROCEDURE, THE PATIENT WENT INTO CARDIAC ARREST W... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRAOPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO CLAIM THAT A MALFUNCTION OF A DA VINCI PRODUCT OCCURRED, AND THERE IS NO INDICATION THAT THE DA VINCI DEVICE DIRECTLY CAUSED THE PATIENT'S CARDIAC ARREST. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITI... |
Brand Name:DAVINCI XDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Hematoma; Hemorrhage/Bleeding; Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED DISTAL PANCREATECTOMY PERFORMED ON (B)(6) 2022, THE PATIENT EXPIRED ON (B)(6)... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION OR REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SYSTEM LOGS WAS PERFORMED FO... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, STAPLE LINE WAS "NOT STABLE" WHERE A CURVED-TIP SUREFORM 45 STAPLER INSTRUMENT WAS FIRED. THE PROCEDURE WAS CONVERTED TO OP... | ON 20-APR-2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM FAILURE ANALYSIS OF THE STAPLER INVOLVED WITH THE EVENT: ISI RECEIVED A PART ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER-REPORTED COMPLAINT THROUGH ER... |
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 SURGICAL PROCEDURE, AN UNKNOWN FRAGMENT WAS FOUND INSIDE THE PATIENT'S ANATOMY AND RETRIEVED IMMEDIATELY UPON BEING SEEN. IT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT A FRAGMENT FROM THE CANNULA SEAL FELL INSIDE THE PATIENT, 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.... |
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 8MM FORCE BIPOLAR INSTRUMENT BROKE AND PART OF THE INSTRUMENT POPPED OFF. IT WAS NOTED THAT NO P... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE OF 8MM FORCE BIPOLAR, 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 FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND T... |
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 CENTRAL PROCESSING, THAT AN 8MM PROGRASP FORCEPS INSTRUMENT BROKE INSIDE THE CANNULA AND WAS HARD TO REMOVE. THERE WAS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT AN 8MM PROGRASP FORCEPS INSTRUMENT BROKE INSIDE THE CANNULA AND WAS HARD TO REMOVE, 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, BUT THE INSTRUMEN... |
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 SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT SUDDENLY WOULD NOT WORK, AND THERE WAS A MESSAGE REQUESTING TO REPLACE THE H... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF THE BROKEN BLADE TO BE RELATED TO THE CUSTOMER REPORTE... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT AFTER A COMPLETED ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND HOSPITALIZATION. THE LESION WAS BIOPSIED IN ... | 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. AS OF 20-DEC-2022, A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE. THIS COMPLAIN... |
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 WAS UNABLE TO CLIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INSTRUMENT WAS UNABLE TO CLIP, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS ANALYZ... |
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 GASTRECTOMY SURGICAL PROCEDURE, THERE WERE REPEATED ERROR M-36 ON THE ERBE VIO POINTING TO BOTH MONOPOLAR PORTS. THE SITE CHANGED THE... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE CONFIRMED THE REPORTED ISSUE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE IESU GENERATO... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of Device; ArcingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER OBSERVED ELECTRIC LEAKAGE FROM THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE CUSTOMER... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD ELECTRIC LEAKAGE, 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 CU... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED A SMALL PNEUMOTHORAX. THIS WAS DISCOVERED VIA CHEST X RAY AFTER THE PROCEDURE. A CHEST ... | BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. HOWEVER, PER THE PHYSICIAN, THE PNEUMOTHORAX CAN BE ATTRIBUTED POSSIBLY TO THE PATIENT'S CONDITION AND WOULD HAVE LIKELY OCCURRED VIA ANOTHER MODALITY. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM... |
Brand Name:DAVINCI SIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO REPORT THAT ERROR 23017 OCCURRED, AND THEY COULD NOT USE PATIENT SIDE MANIPULATOR (... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MASTER TOOL MANIPULATOR (MTM) GIMBAL ASSEMBLY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATIONS OF THE RETURNED ASSEMBLY CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE FA INVESTIGATIONS REPRODUCED THE REPORTED FAILURE (ERRO... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of Device; SparkingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A SPARK. THE CUSTOMER REPLACED THE FENESTRATED BIPO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A SPARK, 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 FORC... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Failure to AnastomoseEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THE SUREFORM 60 STAPLE LINE HAD A LEAK. BEFORE THIS STAPLE RELOAD WAS FIRED, THERE WAS AN ENGAGEMENT ERROR AND THE SURGEON MANUA... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION HAS BEEN DEEMED TO BE PRODUCT RELATED. ISI REQUESTED THE CUSTOMER RETURN THE STAPLER RELOADS INVOLVED WITH THIS REPORTED EVENT, BUT NO PRODUCTS HAVE BEEN RECEIVED AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAIN... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Failure to AnastomoseEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THE SUREFORM 60 STAPLE LINE HAD A LEAK. BEFORE THIS STAPLE RELOAD WAS FIRED, THERE WAS AN ENGAGEMENT ERROR AND THE SURGEON MANUA... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION HAS BEEN DEEMED TO BE PRODUCT RELATED. ISI REQUESTED THE CUSTOMER RETURN THE STAPLER RELOADS INVOLVED WITH THIS REPORTED EVENT, BUT NO PRODUCTS HAVE BEEN RECEIVED AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAIN... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Failure to AnastomoseEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THE SUREFORM 60 STAPLE LINE HAD A LEAK. BEFORE THIS STAPLE RELOAD WAS FIRED, THERE WAS AN ENGAGEMENT ERROR AND THE SURGEON MANUA... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION HAS BEEN DEEMED TO BE PRODUCT RELATED. ISI REQUESTED THE CUSTOMER RETURN THE STAPLER RELOADS INVOLVED WITH THIS REPORTED EVENT, BUT NO PRODUCTS HAVE BEEN RECEIVED AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAIN... |
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 SUREFORM 45 STAPLER INSTRUMENT WAS NOT RESPONSIVE TO THE SURGEON'S CONTROL. THE INSTRUMENT MOVES LEFT / RIGHT IN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE MOTION, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE... |
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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, ONE OF THE SURGEON SIDE CONSOLE (SSC) EYES WENT OUT. THE CUSTOMER POWER CYCLED AND HARD CYCLED THE EFF... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A LOSS OF VISION IN ONE OF THE SSC EYES, 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 EVEN... |
Brand Name:DAVINCI XIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Bowel Perforation; Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, AN UNSPECIFIED COMPLICATION OCCURRED. THE CAUSE, TYPE, SEVERITY, AND... | INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE SURGEON: THE SURGEON COULD NOT RECALL WHICH OF THE TWO INGUINAL HERNIA PROCEDURE PATIENTS WAS INVOLVED IN THE REPORTED INCIDENT. THE SURGEON CONFIRMED THAT THE ROBOTIC INGUINAL HERNIA PROCEDURE WAS COMPLETED WITH NO REPORTED ISSUES. APPROXIMATEL... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI- ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE WIRE AT THE TENACULUM FORCEPS INSTRUMENT TIP WAS CUT. THE PROCEDURE WAS CO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKEN CABLES, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN D... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, A STAPLE LINE LEAK OCCURRED. IT IS UNKNOWN HOW THE POST-OPERATIVE LEAK WAS DISCOVERED. THE STAPLE LIN... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. ISI REQUESTED THE CUSTOMER RETURN THE SUREFORM 60 RELOAD(S) INVOLVED WITH THIS REPORTED EVENT, BUT PRODUCTS HAVE BEEN RECEIVED AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM L... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device Component; No Apparent Adverse EventPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI- ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE WIRE AT THE TENACULUM FORCEPS INSTRUMENT TIP WA... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED, THE TENACULUM FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) FOUND THE PRIMARY FAILURE OF BROKEN DISTAL PITCH CABLE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOU... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, A STAPLE LINE LEAK OCCURRED. IT IS UNKNOWN HOW THE POST-OPERATIVE LEAK WAS DISCOVERED. THE STAPLE LIN... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. ISI REQUESTED THE CUSTOMER RETURN THE SUREFORM 60 RELOAD(S) INVOLVED WITH THIS REPORTED EVENT, BUT PRODUCTS HAVE BEEN RECEIVED AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM L... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT AFTER AN ION TRANSBRONCHIAL PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND HOSPITALIZATION. THE PROCEDURE WAS COMPLETED, BUT NO DIAGNOSIS W... | 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. AS OF (B)(6) 2022 , A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY A INTUITIVE... |
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 PROSTATECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT BROKE WHILE INSIDE THE PATIENT FOLLOWING A... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE MAIN TUBE BROKEN. PIECES MEASURING APPROXIMATELY 0.291" X 0.551" AND 0.280" X 0.352" WERE NOT RETURNED WITH THE INSTRUMENT. AS A R... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Failure to AnastomoseEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, A STAPLE LINE LEAK OCCURRED IN RELATION TO AN ANASTOMOSIS. THE STAPLE LINE ALLEGEDLY FELL APART POST-OPERATIVELY. THE STAPLE LIN... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. ISI REQUESTED THE CUSTOMER RETURN THE SUREFORM 60 RELOAD(S) INVOLVED WITH THIS REPORTED EVENT, BUT NO PRODUCTS HAVE BEEN RECEIVED AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. THE STA... |
Brand Name:SUREFORMDevice Problem: Failure to CutPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT, LOADED WITH A BLUE SUREFORM 60 RELOAD, DID NOT CUT THE TARGET TISSUE DURING THE... | BASED ON THE CUSTOMER'S CLAIM AGAINST THE PRODUCT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THE RETURN OF THE STAPLER RELOAD AND INSTRUMENT FOR FAILURE ANALYSIS. HOWEVER, AS OF THE DATE OF THIS REPORT, ISI HAS NOT RECEIVED THE PRODUCTS F... |
Brand Name:NONEDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE INSTRUMENTS MOVED WITH NON-INTUITIVE MOTION. THE CUSTOMER CONFIRMED THAT THEY USING A 30-DEGREE E... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE INSTRUMENTS MOVED WITH NON-INTUITIVE MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE CUSTOMER REMOVED THE INSTRUMENTS, AND POWER CYCLED THE SYSTEM TO RESOLVE THE ISSUE. NO SITE VISIT WAS CONDUCTED. THE SYSTE... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD AN ERROR U-02 ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU/ERBE). THE CUSTOMER POWER CYCLE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ERROR U-02 ON THE ERBE, 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 REP... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THE CARRIAGE ON UNIVERSAL SURGICAL MANIPULATOR (USM)4 WAS VERY LOOSE AND THE STAFF WAS CONCERNED THE USM MIG... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS WAS ABLE TO CONFIRM/REPRODUCE THE REPORTED COMPLAINT. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WITH NO TRIGGERED ERRORS. HOWEVER, THE SPAR LI... |
Brand Name:ENDOWRISTDevice Problem: Dull, BluntPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THAT THE EDGE OF THE MONOPOLAR CURVED SCISSORS (MCS) BLADES WERE ROUGH/ BARBED. THEY CAUGHT TISSUE WHILE IN USE. THE PROCEDURE W... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BLADE ISSUES AND THE MONOPOLAR CURVED SCISSORS (MCS) GETTING CAUGHT IN TISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MCS IN... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD A BROKEN CABLE. A BACKUP INSTRUMENT OF SAME KIND WA... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE TENACULUM FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) FOUND THE PRIMARY FAILURE OF BROKEN DISTAL PITCH CABLE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOUN... |
Brand Name:DAVINCI XIDevice Problem: Power ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) SURGICAL PROCEDURE, THE PATIENT SIDE CART (PSC) WAS RUNNING ON BATTERY. THE LIVE LOGS INDICATED THE SYSTEM FAULTED W... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. BASED ON THE FIELD EVALUATION, THE FSE COULD NOT RECREATE THE POWER ISSUE WHILE SERVICING THE SYSTEM. HOWEVER, THE TWO POWER SUPPLIES (UNIVERSAL POWER DISTRIBUTOR (UPD)) WERE... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY TRANSTHORACIC SURGICAL PROCEDURE, THE CUSTOMER WAS NOT ABLE USE THE HARMONIC ACE INSTRUMENT AS THERE WAS NO BLUE LED ON PERSONALIT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NOT ABLE USE THE HARMONIC ACE INSTRUMENT AS THERE WAS NO BLUE LED ON PMED, 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 REP... |
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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CLIP APPLIER INSTRUMENT WOULD NOT RELEASE THE CLIP ONCE IT WAS APPLIED ON TISSU... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DISCREPANT PRODUCT RETURN OF ANOTHER MEDIUM-LARGE CLIP APPLIER INSTRUMENT WITH LOT K10220104/0111 FROM THE SITE WITH NO ALLEGATION OF A PRODUCT ISSUE. FAILURE ANALYSIS WAS PERFORMED AND COMPLETED FOR THIS DISCREPANT RETURN. INVESTIGATION CONFIRMED THAT THE INSTRUMENT OPERATED A... |
Brand Name:ENDOWRISTDevice Problem: Failure to Form StaplePatient Problem: Failure to Anastomose; Sepsis; PeritonitisEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THE CUSTOMER UNDERWENT A REVISION SURGERY ON POST-OPERATIVE DAY (POD) #3 VIA OPEN TECHNIQUE BY THE SAME SU... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S POST-OPERATIVE COMPLICATION CAN BE ATTRIBUTED TO A STAPLE LINE LEAK ACCORDING TO THE SURGEON. ISI HAS NOT RECEIVED THE STAPLER INSTRUMENT OR RELOAD(S) INVOLVED WITH THIS COMPLAINT. THEREFORE, THE ROOT CAUSE OF THE ALLEGED CUSTOMER REPORTED FAILURE MO... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT AFTER COMPLETION OF AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LESION WAS IN THE RIGHT MIDDLE LOBE - MEDIAL SEGMENT. ... | 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. PER AN INTUITIVE SURGICAL, INC. (ISI) SENIOR FAILURE ANALYSIS ENGINEER (FAE), AS OF (B)(6) 2022, A REVIEW OF THE SI... |
Brand Name:DAVINCI XIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Hypoxia; Low Oxygen SaturationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY WITH NECK ANASTOMOSIS PROCEDURE, THE PATIENT¿S SPO2 DECREASED. ACCORDING TO THE INITIAL... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED ALTHOUGH THE SURGEON ATTRIBUTED THE DECREASE IN SPO2 TO THE PATIENT'S PRE-EXISTING POOR LUNG FUNCTION. THERE IS NO ALLEGATION OR REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. A FOLLOW-UP MDR... |
Brand Name:DAVINCI XIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT AFTER COMPLETION A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE PATIENT PASSED AWAY FROM AN UNSPECIFIED CAUSE. INTUITIVE SURGICAL, INC. (... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S DEATH IS UNKNOWN. ISI HAS ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT/INCIDENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP ... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR WAS NOT FIRING AND THE SYSTEM HAD AN ERROR MESSAGE C-34. THE CUSTOMER TRIED REBOOTING INT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERBE ERROR, 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. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED... |
Brand Name:ENDOWRISTDevice Problem: Melted; No Apparent Adverse EventPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO STARTING AN UNSPECIFIED DA VINCI ASSISTED SURGICAL PROCEDURE, THE SURGEON DID NOT WANT TO USE THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT AND ASK... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE CHARRING AND LOCALIZED... |
Brand Name:NONEDevice Problem: Thermal Decomposition of Device; 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 THYROIDECTOMY SURGICAL PROCEDURE, WHEN THE CUSTOMER WAS USING THE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE TEFLON PAD MELTED AND THE POWDER FELL INTO THE PATIENT, 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 B... |
Brand Name:DA VINCI SPDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Hemorrhage/Bleeding; Unspecified Tissue InjuryEvent Description: IT WAS REPORTED AS PART OF A CLINICAL STUDY THAT A PATIENT UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE FOR A 4CM LESION WITH THE ... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED ALTHOUGH THE SURGEON ASSESSED THE CAUSALITY AS UNLIKELY IN RELATION TO THE DA VINCI SURGICAL SYSTEM. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED .... |
Brand Name:DAVINCI XDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY SURGICAL PROCEDURE, ARM1 WAS OUT OF SYNCH. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND NO ERRORS FO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ARM1 WAS OUT OF SYNC, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE FSE REPLACED THE MASTER TOOL MANIPULATOR (MTM) AND UNIVERSAL SURGICAL MANIPULATOR (USM) TO CORRECT THE REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE ... |
Brand Name:SUREFORMDevice Problem: Failure to Form Staple; Failure to CutPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT FIRED A BLUE SUREFORM 60 RELOAD AND PUSHED/BUNCHED THE TARGET TISSUE INST... | INTUITIVE SURGICAL INC. (ISI) RECEIVED THE SUREFORM 60 STAPLER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED AND CONFIRMED THE REPORTED ENGAGEMENT ISSUES. FOR CLARIFICATION, THE INSTRUMENT FAILED TO ENGAGE PROPERLY WITH THE STERILE ADAPTERS ON THE SYSTEM DURING... |
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 HYSTERECTOMY SURGICAL PROCEDURE, THE E-100 GENERATOR WAS NOT RECOGNIZING THE VESSEL SEALER EXTEND (VSE) INSTRUMENT. CUSTOMER STATED THAT ... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE INVESTIGATION FOUND NEST_PIC NOT CHECKED IN DOWNLOAD APP. THE FSE ENABLED THE NEST_PIC AND THE ISSUE WAS RES... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Bradycardia; Cardiac Arrest; Low Blood Pressure/ HypotensionEvent Description: IT WAS REPORTED DURING THE BIOPSY PORTION OF AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT'S HEART RATE DROPPED AND SHE CODED. THE L... | 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. AS OF (B)(6) 2022, A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE. THIS COMPLAIN... |
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 PATIENT SIDE CART (PSC) STARTED RUNNING ON BATTERY. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) R... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE PATIENT SIDE CART (PSC) STARTED RUNNING ON BATTERY, 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 T... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GYNECOLOGY HYSTERECTOMY BENIGN SURGICAL PROCEDURE, THERE WAS A MESSAGE TO REMOVE HEAD FROM VIEWER MESSAGE. THE SITE HAD RESTARTED THE SYSTEM DUE... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. BASED ON THE FIELD EVALUATION, THE FSE WAS NOT ABLE TO REPRODUCE THE ISSUE. THE FSE REPLACED THE SURGEON HEAD SENSOR (SHS) TO ACCOUNT FOR THE INTERMITTENT ERROR MESSAGE AS RE... |
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