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Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED INGUINAL UNILATERAL HERNIA SURGICAL PROCEDURE. THAT THE 30-DEGREE ENDOSCOPE FLIPPED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY... | BASED ON THE CLAIM AGAINST THE PRODUCT, BY THE CUSTOMER NOTING UNINTUITIVE MOTION OF THE ENDOSCOPE. AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENDOSCOPE FOR FAILURE ANALYSIS (FA). HOWEVER, FA IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE SUBMI... |
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 FENESTRATED BIPOLAR FORCEPS WAS OBSERVED TO HAVE THE BLACK COATING DAMAGED ON THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT. ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INSULATION DAMAGE ON BLACK CABLE OF FENESTRATED BIPOLAR FORCEPS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE IN... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING OF A DA VINCI-ASSISTED COLORECTAL SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY HAD SOME FAULTS ON UNIVERSAL SURGICAL MAN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNIVERSAL SURGICAL MANIPULATOR (USM) 3 NOT RESPONSIVE 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 ... |
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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL INC (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED THE ISI TECHNICAL SER... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING MONOPOLAR FIRING ISSUE DUE TO GENERATOR FAULT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE FSE CONFIRMED THAT THE ERBE FAULTED WITH M-02 ERROR DURING POWER ON SELF-TEST. THEREFORE, FSE REPLACED THE ERBE (PART NO: 951300-... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THEY RECEIVED AN ERROR 23. THE TSE VIEW... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING CONNECTIVITY ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE ISI FIELD SERVICE ENGINEER CONFIRMED WITH THE CUSTOMER THAT AFTER TROUBLESHOOTING WITH THE ISI TECHNICA... |
Brand Name:DAVINCI XIDevice Problem: Positioning FailurePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ARM 2 WITH INSTALLED ENDOSCOPE SUDDENLY MOVED. THE ENDOSCOPE MOUNTED ON ARM 2 SUDDENLY MOVED A BIT WHILE THE SURGEO... | 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. BASED ON THE FIELD EVALUATION, THIS REPORTED... |
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 VAGINAL PROLAPSE REPAIR SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1 WAS SWINGING FREELY WHILE DOCKING. INTUITIVE SURGICAL, ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SWINGING FREELY WHILE DOCKING, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER USED THE SYSTEM FOR MULTIPLE CASES SINCE THE REPORTED EVENT WITHOUT ANY ISSUES.... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE INSTRUMENT HAD EXPOSED WIRES. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING EXPOSED WIRES, 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 ... |
Brand Name:ENDOWRISTDevice Problem: Material Frayed; SmokingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, WHILE USING THE CAUTERY FUNCTION THE JOINT BETWEEN THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT AND ... | BASED ON THE CLAIMS BY THE CUSTOMER AGAINST THE PRODUCT NOTING SMOKE, 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 INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CO... |
Brand Name:NONEDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE ENDOSCOPE HAD UNSPECIFIED ROTATIONAL ISSUES. THERE WERE NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ROTATIONAL ISSUES WITH ENDOSCOPES DURING A PROCEDURE, 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. THIS COM... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE PLASTIC TIP OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS CHIPPED/MELTED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. FOLLOW-UP WITH THE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THERMAL DAMAGE AND CHIPPING ON THE FENESTRATED BIPOLAR FORCEPS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PART ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FA... |
Brand Name:ENDOWRISTDevice Problem: Energy Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING THE PROCEDURE A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, SMOKE WAS COMING FROM THE PERMANENT CAUTERY HOOK INSTRUMENT. THE PROCEDURE WA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SMOKE COMING FROM THE 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 PERMANENT CAUTERY HOOK (PCH) INSTRUMENT WAS ANALYZED AND F... |
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 CUSTOMER REPORTED THE SURGEON COMPLAINED OF TINY BLUE SPECKS IN AND ON HER INSTRU... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTHING FOREIGN BODIES FOUND IN THE PATIENT, 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 CONTRIBUTI... |
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 SACROPOLPOPEXY WITH HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED A REPEATED NON-RECOVERABLE 23118 ERROR ON THE SYSTE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE REPEATED SYSTEM ERROR FAULT AND A USM ARM BEING NON 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 IN... |
Brand Name:NONEDevice Problem: Material SeparationPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) WAS REMOVED FROM THE ARM AND THEN THE CUSTOMER NOTICED THAT THE MCS TIP COVER ACCESSORY WAS MISSING WHEN RE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A MISSING MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY, 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... |
Brand Name:ENDOWRISTDevice Problem: Material SeparationPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CLIP FELL OFF THE MEDIUM-LARGE CLIP APPLIER THREE TIMES WHEN ATTEMPTING TO USE IT ON TISSUE. THE CLIP WAS RETRIEVED, A... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE CLIP FALLING INSIDE THE PATIENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFI... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX WHICH REQUIRED A CHEST TUBE PLACEMENT. IT WAS STATED THAT THE PATIENT THEN REQUIR... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. PER AN INTUITIVE SURGICAL, INC. (ISI) ADVANCED FAILURE ENGINEER, A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAIL... |
Brand Name:DAVINCI SIDevice Problem: No Display/ImagePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO START, POST ANESTHESIA OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE SURGEON SIDE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SSC RIGHT EYE VISION LOSS, 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... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE CONNECTION PART OF THE FORCE BIPOLAR INSTRUMENT WAS DAMAGED, AND THE INSTRUMENT TIP WAS NO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BENT FORCE BIPOLAR INSTRUMENT WRIST, AN INVESTIGATION IS IN PROGRESS. THE FORCE BIPOLAR INSTRUMENT HAS NOT YET BEEN RETURNED TO ISI FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT YET BE DETERMINED. A FOLLOW-UP MDR WILL... |
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 DEVELOPED A PNEUMOTHORAX REQUIRING PLACEMENT OF A CHEST TUBE AND HOSPITALIZATION. A FEW DAYS ... | 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 COMPLAINT IS BEING REPORTED... |
Brand Name:DA VINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER RECEIVED ERROR 86. THE CUSTOMER POWERED CYCLED THE SYSTEM AND ERROR COME BACK. ON... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE CUSTOMER POWER CYCLED THE SYSTEM WITH NO SUCCESS. THE FSE REPLACED THE CORE TO RESOLVE THE ISSUE. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL... |
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 CARDIAC SURGICAL PROCEDURE, THE SYSTEM WAS GETTING A RECOVERABLE FAULT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGI... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED/TESTED ON AN IN-HOUSE SYSTEM A... |
Brand Name:DA VINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY RADICAL WITH LYMPHADENECTOMY SURGICAL PROCEDURE, ERRORS C-34 ON VIO ERBE OCCURRED DURING BIPOLAR ENERGY ACTIVATION. PER TECHNICAL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ISSUE WITH BIPOLAR ENERGY, 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 REPL... |
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 PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 MOVED/DRIFTED ON IT OWN AND HAD SOME ISSUE WITH CLU... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING DRIFTED ON ITS OWN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE FIELD SERVICE ENGINEER CONTACTED THE ISI CSR WHO WENT ONSITE AFTER THE CUSTOMER CONTACTED HIM. THE CUST... |
Brand Name:ENDOWRISTDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Hemorrhage/BleedingEvent Description: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI ASSISTED PULMONARY LOBECTOMY, THE VESSEL SEALER EXTEND (VSE) WAS "NOT FUNCTIONING PROPERLY TORE THROUGH A VESSEL." THROUGH FOL... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED INCOMPLETE SEAL AFTER USING THE VESSEL SEALER EXTEND (VSE) INSTRUMENT IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT AND PERFORMED FAILURE ANALYSIS WHICH DID NOT CONFIRM NOR REPLICATE THE CUSTOMER REPORTED COMPLAINT. DURIN... |
Brand Name:DAVINCI XIDevice Problem: Physical Resistance/StickingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE LARGE NEEDLE DRIVER (LND) INSTRUMENT WAS STUCK IN THE UNIVERSAL SURGICAL MANIPULATOR (... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE REPORTED ISSUE VIA REMOTE FE AND NOT REPLICATED DURING IN-HOUSE TESTING. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED/TES... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTEROTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED REPEATED U-02 ERROR ON THE ERBE. THE CUSTOMER HAS POWER CYCLED THE SYSTEM BUT THE I... | 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 FSE REPLACED THE INTEGRATED ELECTROSURGI... |
Brand Name:NONEDevice Problem: Failure to SensePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL INGUINAL HERNIA UNILATERAL SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE ENDOSCOPE BEING UPSIDE DOWN AFTER AN ERROR. THE CUSTOMER HAD RESEAT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INVERTED IMAGE, 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 C... |
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 PANCREATECTOMY SURGICAL PROCEDURE, ONE OF THE TIPS OF HARMONIC ACE INSTRUMENT FELL OFF. THE TIP WAS RETRIEVED IN THE SAME PROCEDURE WITH NO PA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING HARMONIC ACE TIP FALLING INTO THE PATIENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE TIP WAS RETRIEVED DURING THE SAME PROCEDURE. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INF... |
Brand Name:DAVINCI SIDevice Problem: Overheating of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER OBSERVED AN ALLEGED "BURNT SMELL" COMING FROM THE VISION SIDE CART (VSC). THE CUSTOMER RECEIVED PHONE AS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ALLEGED "BURNT SMELL" COMING FROM THE VISION SIDE CART (VSC), 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 INVES... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, POST-ANESTHESIA AND POST-SURGICAL PORT PLACEMENT, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED NON-RECOVERABLE ERROR 26002, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. ... |
Brand Name:NONEDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE CLEANING FLAP ON THE PORT OF THE 30 DEGREE ENDOSCOPE NO LONGER SNAPPED INTO PLACE, AND THE CUSTOMER COULD NOT CONNECT THE CAMERA AT ALL. THE PROCEDURE WAS COMPLETE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE CLEANING FLAP ON THE PORT OF THE 30 DEGREE ENDOSCOPE NO LONGER SNAPPED INTO PLACE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. TH... |
Brand Name:DAVINCI XIDevice Problem: Failure to Deliver EnergyPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE THAT THE BIPOLAR ENERGY WAS NOT WORKING. THE CUSTOMER STATED THAT THE ENERGY WAS INTERMITTENT,... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE BIPOLAR ENERGY WAS NOT WORKING, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) WAS ... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Stroke/CVAEvent Description: IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE THE PATIENT WOKE UP AND IMMEDIATELY EXPERIENCED AN ACUTE ISCHEMIC STROKE. THE PATIENT SUFFERED LEFT-SIDED WEAKNESS AND "NE... | BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THERE WAS 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. REVIEW OF THE PROCEDURE VIDEO CONFIRMS T... |
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 PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 WAS FLOATING WHENEVER SURGICAL FIELD TOOK CONTROL OF IT. THE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNIVERSAL SURGICAL MANIPULATOR (USM) 2 FLOATING, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE FIELD SERVICE ENGINEER CONTACTED THE CUSTOMER WHO PERFORMED A SYSTEM POWER... |
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 LIVER RESECTION SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER WAS OBSERVED TO HAVE NOT SEALED/CLIPPED. THE PROCEDURE WAS COMPL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE CLIP APPLICATION 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 THE CONTRIBUTION OF THE DEVICE TO THE ... |
Brand Name:NONEDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED FOR MONTHS THE SURGEON COMPLAINED OF TINY BLUE SPECKS IN AND ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTHING FOREIGN BODIES FOUND IN THE PATIENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CANNULA SEAL PORTS INVOLVED WITH THIS COMPLAINT. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICAT... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED IN TO REPORT THAT ERROR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT ERROR C-00 OCCURRED ON THE INTEGRATED ERBE ELECTROSURGICAL GENERATOR UNIT (IESU), AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER... |
Brand Name:ENDOWRISTDevice Problem: Material Fragmentation; Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYMECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT JAWS WERE NOT HOLDING THE TISSUE PROPERL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NOT MOVING IN RIGHT DIRECTION, 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 ... |
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:ENDOWRIST;DAVINCI SIDevice 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 MONOPOLAR CURVED SCISSORS INSTRUMENT WAS ALLEGEDLY FRACTURED ON THE FRONT END. THE P... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE INSTRUMENT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE DID CONTRIBU... |
Brand Name:SUREFORMDevice Problem: Firing ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT WAS FIRING ACROSS A BRONCHUS AND RECEIVED AN ERROR MESSAGE STATING THE TISSU... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE STAPLES MISSING FROM THE LINE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI SURE FORM 45 GREEN RELOAD TO PERFORM FAILURE ANALYSIS. THE SURE FORM 45 GREEN RELOAD WAS AN... |
Brand Name:ENDOWRISTDevice Problem: Material FrayedPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A BROKEN WRIST CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AN ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN WRIST 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 WAS ANALYZED, AND FAILURE ANALYSIS ... |
Brand Name:ENDOWRISTDevice Problem: Firing ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE USER ALLEGED THAT THE PROGRASP FORCEPS INSTRUMENT WAS UNABLE TO RELEASE THE TISSUE AND THAT IT "CONTINUALLY GOT STUCK TOG... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INSTRUMENT GRIP FAILURE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ALTHOUGH THE COMPLAINT REGARDING REPORTED FAILURE WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE INSTRUMENT WAS NOT RETURNED, THE INFORMATION GATHERED IND... |
Brand Name:SUREFORMDevice Problem: MisfirePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BARIATRIC REVISION SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER RELOAD WAS MISFIRED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING MISFIRE, 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 BLUE SUREFORM 60 RELOAD WAS ANALYZED AND FOUND TO HAVE THE KNIFE EXPOSED WIT... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS NOT WORKING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NOT WORKING, AN INVESTIGATION IS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND THE PRIMARY FA... |
Brand Name:SUREFORMDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER EXPERIENCED A JAW FAILURE WHEN THE JAWS WERE UNCLAMPED. A BACKUP STAPLER WAS U... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SUREFORM 45 STAPLER EXPERIENCED A JAW FAILURE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE SUREFORM 45 STAPLER WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS WERE ABLE TO CONFIRM THE REPORTED ISSUE. FAILURE ANALYS... |
Brand Name:SUREFORMDevice Problem: Defective Component; Failure to Form Staple; Firing ProblemPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT WHILE USING A SUREFORM 60 INSTRUMENT WITH A BLACK SUREFORM 60 RELOAD DURING A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY WITH CHEST ANASTOMOS... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE TISSUE PUSHOUT EVENT IS UNKNOWN. THE SUREFORM 60 INSTRUMENT AND SUREFORM 60 BLACK RELOAD WERE RETURNED TO INTUITIVE SURGICAL, INC. (ISI) AND FAILURE ANALYSIS (FA) FOUND THE SUREFORM 60 BLACK RELOAD TO HAVE THE KNIFE EXPOSED WITHIN THE KNIFE TRACK. THE MOST PRO... |
Brand Name:DAVINCI SIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Ischemia; Necrosis; SeromaEvent Description: ON 28-MAR-2023, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY ARTICLE TITLED, ¿ROBOTIC VERSUS CONVENTIONAL NI... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE COMPLICATIONS 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 ... |
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 HAD HORIZON/IMAGE ORIENTATION ISSUES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. IN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INVERTED, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUST... |
Brand Name:DA VINCI SPDevice 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 THAT THE MONOPOLAR ENERGY WAS NOT WORKING. THE SITE KEPT GETTING MESSAGES TO CHECK THE MONOPOLAR ENERGY CORD,... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE MONOPOLAR ENERGY WAS NOT WORKING, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND PLUGGED THE SUSPECTED INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) INTO ... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED URETERAL REIMPLANTATION SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT ARM 1 WAS GIVING AN ERROR MESSAGE AB... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ARM 1 WAS GIVING AN ERROR MESSAGE ABOUT LIMITED MOVEMENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ISI HAS RECEIVED THE UNIVERSAL SURGICAL MANIPULA... |
Brand Name:SUREFORMDevice 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 SUREFORM STAPLER HAD INAPPROPRIATE MOVEMENTS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INAPPROPRIATE MOVEMENT, 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 CUST... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Transient Ischemic AttackEvent Description: IT WAS REPORTED THAT A PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND EXPERIENCED TRANSIENT ISCHEMIA OF THE BRAIN. IT WAS REPORTED THAT THE TRANSIENT ISCHEMIC ... | BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (IS... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE 30-DEGREE ENDOSCOPE COULD NOT BE CONTROLLED. ARMS WERE LOSING ORIENTATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) M... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE ENDOSCOPE COULD NOT BE CONTROLLED, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE 30-DEGREE ENDOSCOPE, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. AS SUCH, THE PROBABLE ... |
Brand Name:SUREFORMDevice 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 CUSTOMER REPORTED THAT THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 STAPLER WAS MOVING ON I... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE UNIVERSAL SURGICAL MANIPULATOR (USM) MOVING ON ITS OWN, 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:NONEDevice Problem: Image Orientation IncorrectPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN ENDOSCOPE HAD UNSPECIFIED ROTATIONAL ISSUES. IT IS UNKNOWN IF THE ISSUE WAS WITH A 0-DEGREE OR 30-DEGREE ENDOSCOPE. THERE WERE NO ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT AN ENDOSCOPE HAD ROTATIONAL ISSUES DURING A PROCEDURE. 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. AT... |
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:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND HOSPITALIZATION. THE BIOPSIED LESION WAS 0.8CM I... | 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 COMPLAINT IS BEING REPORTED... |
Brand Name:DAVINCI XDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA-UNILATERAL SURGICAL PROCEDURE, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED RE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ERROR 319 ON THE USM 1, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE ISI FSE... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO REMOVE THE PROGRASP FORCEPS INSTRUMENT. THE CUSTOM... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 8MM PROGRASP FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A FRAYED GRIP CABLE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL END. COMMON CAUSES OF THE FAILU... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH NEOBLADDER SURGICAL PROCEDURE, THE IMAGE FROM THE 30-DEGREE ENDOSCOPE WAS MIRRORED. THE PROCEDURE WAS COMPLETING ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN IMAGE MIRRORING 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 ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE ENDOSCOPE ADAPTER ... |
Brand Name:DAVINCI XIDevice Problem: Poor Quality ImagePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED COMMON BILE DUCT EXPLORATION SURGICAL PROCEDURE. THE RIGHT IMAGE OF THE SURGEON SIDE CONSOLE (SSC) 1 (SIMULATOR WAS INSTALLED TO) BECAME BL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING, BLACK RIGHT IMAGE. AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE CONFIRMED... |
Brand Name:SUREFORMDevice Problem: Failure to CutPatient Problem: Unspecified Tissue Injury; Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE SUREFORM 60 STAPLER EXPERIENCED AN UNEVEN CUT. THE ISSUE OCCURRED DURING GASTRIC STAPLING. THE SUREFOR... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THE DEVICE INVOLVED WITH THIS EVENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. REVIEW OF THE SYSTEM LOG WAS NOT COMPLETED SINCE TH... |
Brand Name:ENDOWRISTDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER FAILED. THERE WAS NO REPORTED PATIENT IMPACT OR HARM. INTUITIVE SURGICAL, ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN UNSPECIFIED ISSUE WITH THE INSTRUMENT. AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS AN... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, THE SURGEON HAD NO CONTROL OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT AND THAT THE INSTRUMENT TIPS MOVED UP AND DOWN ON THEI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS WAS ANALYZED AND FOUND TO HAVE THE FAILURE. THE INSTRUMENT WAS PLA... |
Brand Name:DAVINCI XIDevice 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 CAMERA FOOT PEDAL ON SURGEON SIDE CONSOLE (SSC) FELL. THE SURGEON INDICATED THAT IT WAS A DANG... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SURGEON SIDE CONSOLE (SSC) CAMERA PEDAL FELL OFF 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 TH... |
Brand Name:SUREFORMDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CURVED-TIP SUREFORM 45 STAPLER WORKED WITHOUT ISSUE, BUT THE CUSTOMER COULD NOT REOPEN THE CURVED-TIP SUREFORM... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SUREFORM STAPLER 45 CURVED TIP INSTRUMENT INVOLVED IN THIS PROCEDURE AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE WRIST CABLE WAS FOUND LOOSE AT THE BACKEND UPON HOUSING REMOVAL. THE JAW COVER AT THE W... |
Brand Name:ENDOWRISTDevice Problem: Failure to SensePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FAILED TO CLIP. THE MEDIUM-LARGE CLIP APPLIER WOULD NOT ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FAILED, AN INVESTIGATION IS PENDING TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEI... |
Brand Name:ENDOWRISTDevice Problem: ArcingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINAL TESTICULAR RESECTION SURGICAL PROCEDURE, SPARKS CAME OUT FROM THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE ROBOTICS COORDINATOR MENTIONED TH... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) FENESTRATED BIPOLAR FORCEPS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE... |
Brand Name:NONEDevice Problem: BreakPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, WHEN THE HARMONIC ACE TIP WAS OPENED, THE WHITE PART UNDER THE BLADE CAME OFF. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION IS IN PROGRESS. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) HARMONIC ACE INSTRUMENT RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device Component; Material Integrity ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CURVED TIP STAPLER 30 INSTRUMENT HAD BLACK RUBB... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE CURVED TIP STAPLER 30 INSTRUMENT HAD BLACK RUBBER AROUND THE WIRES FLAKING OFF ON THE ARTICULATING END, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM... |
Brand Name:ENDOWRIST;DAVINCI SIDevice 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 SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA INSTRUMENT'S TIP BROKE. THE PROCE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVE THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A ... |
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 SMALL GRASPING RETRACTOR HAD A FRAYED CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A FRAYED CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SMALL GRASPING RETRACTOR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A ... |
Brand Name:ENDOWRISTDevice Problem: BreakPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING AN ASSISTED DA VINCI PARTIAL NEPHRECTOMY PROCEDURE, THE PROGRASP FORCEPS (PF) INSTRUMENT WAS BROKEN AND COULD NOT BE EXTRACTED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED I... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE PF INSTRUMENT WAS BROKEN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PF INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BRO... |
Brand Name:ENDOWRISTDevice Problem: Difficult to RemovePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER STATED THAT WHEN ATTEMPTING TO REMOVE THE PROGRASP FORCEPS FROM THE PATIENT, THE INSTRUMENT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE PROGRASP WAS DIFFICULT TO REMOVE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ISI HAS RECEIVED THE PART ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE PROGRASP FORCEPS INSTRUMENT WAS ANALYZED AND FOUND... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) AND REPO... | 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. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPRODUCED THE IS... |
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 RADICAL CYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM LARGE CLIP APPLIER INSTRUMENT WAS WORKING FINE; THEN WOULD NOT CLIP. THE CUSTOMER U... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING CLIP APPLICATION FAILURE, AN INVESTIGATION IS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED. VISUAL IN... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Unspecified Tissue Injury; Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE, THE SUREFORM 60 STAPLER DID NOT STAPLE. THE ISSUE OCCURRED DURING FIRING WHEN THE RELOAD BLADE BEGAN TO... | ON 19-APR-2023, THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT WAS OBTAINED: DURING THE THIRD FIRING OF THE SUREFORM 60 STAPLER WITH BLUE RELOAD, SEVERAL STOPS WERE MADE FOR COMPRESSION, THEN AN ERROR MESSAGE SHOWED ¿STAPLER FAILED, TAP THE BLUE PEDAL TO LOOSEN IT, AND THEN REMOVE THE STAPLER. WARNING: B... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Remove; Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT WAS DIFFICULT TO REMOVE AND THE USER HAD TO TW... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING DIFFICULTY WITH INSTRUMENT REMOVAL, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVE THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PROGRASP FORCEPS INSTRUMENT WAS ANALYZED AND FOUND ... |
Brand Name:NONEDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS DAMAGED. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE S... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE, AN INVESTIGATION IS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS FOUND THE P... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARAOESOPHAGEAL HERNIA REPAIR SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED ERROR U-02 ON THE INTEGRATED ELECTROSURGICAL UNIT (IES... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR U-02, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE IESU ... |
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, THE CUSTOMER RECEIVED A NON-RECOVERABLE FAULT. THE TECHNICAL SUPPORT ENGINEER (TSE) STATED THE LOGS CONFIRMED... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-RECOVERABLE FAULT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. AFTER TROUBLESH... |
Brand Name:ENDOWRISTDevice Problem: Energy Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD NO COAGULATION DESPITE OF CHANGING THE CABLE. THE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT'S COAGULATION NOT WORKING, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIP... |
Brand Name:ENDOWRISTDevice Problem: Peeled/DelaminatedPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE STARTING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY SURGICAL PROCEDURE, INSPECTION OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT ALLEGED THAT THE "COA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FBF INSTRUMENT WAS ANALYZED AND FOUND TO HAVE DAMAGED CONDUCTOR WIRE ... |
Brand Name:DAVINCI XDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS AN ERROR 252. CUSTOMER WAS UNABLE TO REACH TECHNICAL SUPPORT DUE TO A PHONE PROVIDER ISSUE. CUSTOMER... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERRORS 252, 54 OCCURRED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. CUSTOMER REBOOTED THE SYSTEM AND THE INITIAL ERROR CLEARED BUT ERROR 54 WAS STILL PRESENT. AN INTUITIV... |
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 LAPAROSCOPIC HYSTERECTOMY AND SACROCOLPOPEXY THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT GOT CAUGHT ON THE CANNULA OF ANOTHER INSTRUMENT A... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING FENESTRATED BIPOLAR BROKE MID-SHAFT, 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 FO... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED ERROR U-02 ON THE INTEGRATED ELECTROSURGICAL UNIT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR ON THE 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 SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPRODUCED ... |
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 INSTRUMENT WAS MOVING ON ITS OWN WITHOUT THE SURGEON DOING A... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNINTUITIVE MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER WILL RETURN THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. NO ... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD INSULATION DAMAGE ON THE INSTRUMENT TIP. THERE WAS NO PATIENT INVOLVED. INTUITIVE SURGICAL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INSULATION DAMAGE ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED.... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Non specific EKG/ECG Changes; Low Blood Pressure/ HypotensionEvent Description: IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT¿S BLOOD PRESSURE DROPPED SIGNIFICANTLY. THIS OCCURRED MID... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THE PHYSICIAN REPORTED THAT ANESTHESIA ASSOCIATED HYPOTENSION LED TO EKG CHANGES, LIKELY UNMASKING UNDERLYING CORONARY ARTERY DISEASE. THERE WAS NO REPORT OF ANY ISSUES WITH THE ION SYSTEM, INSTRUMENTS OR ACCESSORIE... |
Brand Name:NONEDevice Problem: Failure to CalibratePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE ENDOSCOPE PLUS 30 DEGREE KEPT TURNING WHEN ENGAGED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE... | 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. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORT... |
Brand Name:ENDOWRISTDevice 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, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED THE MONOPOLA... | 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. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER INDICATES THE ISSUE WAS WITH THE INSTRUMENT. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WOR... |
Brand Name:ENDOWRISTDevice Problem: Material Integrity ProblemPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT, THE FENESTRATED BIPOLAR FORCEPS STOPPED WORKING AND BROKE WHILE INSIDE THE PATIENT. THE INSTRUMENT HAD 5 OUT OF 14 LIVES REMAINING. THE PROCEDURE WAS COMPLETED. NO FURTHER DETAI... | BASED ON THE CLAIM AGAINST THE PRODUCT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED FOR FAILURE ANALYSIS INVESTIGATION. ADDITIONAL INFORMATION IS BEING GATHERED ... |
Brand Name:NONEDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UMBILICAL HERNIA INTRAPERITONEAL ONLAY MESH REPAIR (IPOM) SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE HAD RECO... | BASED ON THE CURRENT INFORMATION PROVIDED, THE SURGEON CONVERTED THE PROCEDURE DUE TO THE PATIENT¿S ANATOMY. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE SITE AND CONFIRMED THAT THERE WERE NO FURTHER ISSUES AFTER USING A DIFFERENT SCOPE ON SUBSEQUENT CASES. A RETURN MATERIAL AUTHO... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: ON 24-MAR-2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MAUDE REPORT NUMBER (B)(4) STATING: INSTRUMENT WAS INSERTED AT THE START OF THE CASE, AND IT WAS NOTED THAT THE GRASPING MECHANIS... | THIS COMPLAINT ORIGINATED FROM A MAUDE REPORT WITH AN UNKNOWN CUSTOMER SITE. INTUITIVE SURGICAL, INC. (ISI) WAS UNABLE TO PERFORM FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION DUE TO THE NATURE OF HOW THIS INFORMATION WAS COLLECTED. ISI HAS NOT RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT.... |
Brand Name:SUREFORMDevice Problem: Failure to CutPatient Problem: Obstruction/Occlusion; Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL CONDUIT SURGICAL PROCEDURE, THE PATIENT UNDERWENT A SUBSEQUENT UNPLANNED PROCEDURE. DURING THE I... | ON 01-MAY-2023, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE FAILURE ANALYSIS OF THE SUREFORM 60 STAPLER: THE SUREFORM 60 STAPLER INSTRUMENT HAS BEEN RECEIVED AND INVESTIGATIONS COMPLETED. FAILURE ANALYSIS INVESTIGATIONS DID NOT CONFIRM OR REPLICATE THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLAC... |
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 LARGE HEM-O-LOK CLIP APPLIER WAS NOT CLOSING AND CLAMPING CLIPS PROPERLY. THE PROCEDURE WAS COMPLETED... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING CLOSING AND CLAMPING ISSUES WITH THE LARGE HEM-O-LOK CLIP APPLIER, 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 CL... |
Brand Name:SUREFORMDevice Problem: Failure to SensePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CURVED-TIP SUREFORM STAPLER 45 INSTRUMENT FAILED TO ENGAGE. THE PROCEDURE WAS COMPLETED WITH NO REPO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ENGAGEMENT 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 CURVED-TIP SUREFORM STAPLER 45 WAS TESTED ON AN IN-HOUSE SYSTEM ... |
Brand Name:SUREFORMDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER EXPERIENCED A JAW FAILURE WHEN THE JAWS WERE UNCLAMPED. A BACKUP STAPLER WAS U... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A JAW FAILURE ON THE SUREFORM 45 STAPLER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE SUREFORM 45 STAPLER WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS WERE ABLE TO CONFIRM THE REPORTED ISSUE. A REVIEW OF SYSTEM LOGS... |
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