BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 15689977 · Received October 28, 2022

    Report

    Report Number
    2955842-2022-14933
    Event Type
    Malfunction
    Date Received
    October 28, 2022
    Date of Event
    September 28, 2022
    Report Date
    September 28, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D02-INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE PSM WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED FAILURE (ERROR 23020 ALONG INSERTION / AXIS 3) WAS ABLE TO BE REPRODUCED DURING POWER UP. THE L4 SWITCH WILL BE REPLACED AS A FIX. ADDITIONAL FINDINGS DURING EVALUATION: THE AXIS 3 BRAKE WILL BE REPLACED DUE TO ERROR 23007. THE AXIS 4 POT FFC WAS FOUND TO BE DAMAGED AND WILL BE REPLACED. THE AXIS 6 POT FFC WAS FOUND TO BE DAMAGED AND WILL BE REPLACED. THE AXIS 7 POT FFC WAS FOUND TO BE DAMAGED AND WILL BE REPLACED. THE LINK 3 GROUND STRAPS WERE FOUND TO BE BENT DURING EVALUATION AND WILL BE REPLACED. THE J19 AND J20 FFC'S WILL ALSO BE REPLACED TO ACCOMMODATE THIS REPAIR. THE J21 FFC WILL BE REPLACED TO ACCOMMODATE THE OUTBOARD BRACKET (J21) REPAIR. THE OUTBOARD BRACKET (J21) WILL BE REPLACED PER MPI 832625. THE CANNULA MOUNT WAS FOUND TO BE PHYSICALLY DAMAGED AND WILL BE REPLACED. THE CANNULA SENSOR WILL BE REPLACED TO ACCOMMODATE THE LINK 4 SWITCH REPLACEMENT. THE CJB PCA WILL BE REPLACED AS A PRECAUTION. THE SFCA BOARD WILL BE REPLACED DUE TO PHYSICAL DAMAGE. THE LINK 4 LOWER PULLEY ASSEMBLY WAS FOUND TO BE CHIPPED DURING AND WILL BE REPLACED. THE LINK 5 LOWER PULLEY ASSEMBLY WAS FOUND TO BE CHIPPED DURING AND WILL BE REPLACED. ROLLING LOOP ASSEMBLY COMPONENTS WILL ALSO BE REPLACED TO ACCOMMODATE THIS REPAIR. THE REAR 8 LINEAR SCREWS AND THE 16 BELLEVILLE WASHERS WILL BE REPLACED TO ACCOMMODATE THE LOWER 5 PULLEY REPAIR. THE LINK 6 TOP SWITCH ASSEMBLY WAS FOUND TO BE CRACKED AND WILL BE REPLACED. THERE WAS AT LEAST ONE COSMETIC DEFECT FOUND DURING EVALUATION THAT WILL REQUIRE TOUCH-UP PAINTING. SEE THE COSMETIC TASK(S) UNDER OP 591 FOR DETAILS.

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE REPORTED EVENT. THE FSE ARRIVED ON SITE AND COULD NOT REPRODUCE THE ERRORS ON PSM3, BUT FOUND THE ERROR IN THE SYSTEM EVENT LOGS. THE FSE REPLACED PSM3. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE PSM FOR EVALUATION; HOWEVER, FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. VERIFICATION OF THE EVENT DETAILS WAS PERFORMED. PER REVIEW, THE FOLLOWING WAS CONFIRMED: A BENIGN HYSTERECTOMY WAS PERFORMED ON SYSTEM (B)(4) ON (B)(6) 2022. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TSE INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERROR: 2302- MANIPULATOR SWITCH FAULT ON PSM3, CANNULA PORT CLUTCH SWITCH. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PSM WAS REPLACED BY THE FIELD SERVICE ENGINEER (FSE) DUE TO AN ISSUE IDENTIFIED AFTER THE START OF THE PROCEDURE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THEY WERE GETTING A REPEATED RECOVERABLE 23020 ERROR ON PATIENT SIDE MANIPULATOR 3 (PSM3). THE TSE VIEWED THE SYSTEM EVENT LOGS AND CONFIRMED THE ERROR. THE TSE HAD THE CALLER CYCLE THE PORT CLUTCH BUTTON MULTIPLE TIMES THE RECOVER FROM THE ERROR. THE ERROR DID NOT RETURN. THE OPERATING ROOM (OR) STAFF PROCEEDED WITH THE CASE AND REQUESTED THEIR FIELD SERVICE ENGINEER (FSE) TO FOLLOW UP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703044 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-07 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female DA VINCI INSTRUMENTS AND ACCESSORIES.