BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15557984 · Received October 7, 2022

    Report

    Report Number
    2955842-2022-14447
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 6, 2022
    Report Date
    September 6, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. TO CORRECT THE ISSUE, FSE REPLACED THE VIO INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU). FOLLOWING SERVICE, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT YET RECEIVED THE VIO IESU FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE WAS CONDUCTED BY A ISI TECHNICAL SUPPORT ENGINEER (TSE) WHEN THE CUSTOMER CALLED IN FOR ASSISTANCE INVESTIGATION REVEALED ERROR C-34 THAT MAY HAVE BEEN RELATED TO THE SYSTEM COMPLAINT. ADDITIONAL LOG REVIEWS CONFIRMED THAT SYSTEM SK0695 WAS USED ON (B)(6)2022 FOR A RADICAL CYSTECTOMY WITH ILEAL CONDUIT PROCEDURE. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO A THIRD PARTY GENERATOR AFTER THE START OF THE PROCEDURE DUE TO THE VIO INTEGRATED ELECTRO SURGICAL GENERATOR UNIT NOT FUNCTIONING PROPERLY. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION FOUND IN: D9, H2, H3, H10 D02 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE IESU VIO INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED AND REPRODUCED THE CUSTOMER COMPLAINT OF AN ERROR C-34 ON THE IESU. THE IESU WAS PLACED ON AN IN-HOUSE SYSTEM AND RAN IN NORMAL MODE. THE UNIT WILL BE RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER FOR REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED RADICAL CYSTECTOMY WITH ILEAL CONDUIT SURGICAL PROCEDURE, THE ELECTRO SURGICAL UNIT (ESU) GENERATOR DISPLAYED AN ERROR C-34. PRIOR TO CONTACTING THE INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE), THE ROBOTICS COORDINATOR STATED THE OPERATING ROOM (OR) TEAM RESTARTED THE GENERATOR, THE ERROR CLEARED, BUT THEN RETURNED. TSE NOTED THAT RESTARTING THE GENERATOR DID NOT RESOLVE THE ISSUE AND THERE WAS NO DEVICE SUSCEPTIBLE TO CREATE INTERFERENCES (SUCH AS CT SCAN IN THE OR). AFTER TSE INSTRUCTED THE CALLER TO PERFORM THE FOLLOWING TROUBLESHOOTING STEPS: CONNECT A FORCETRIAD GENERATOR WITH THE DEDICATED CABLE TO THE VISON SIDE CART (VSC), CONFIRM THAT SURGEON WAS ABLE TO CONTROL THE FORCETRIAD FROM THE SURGEON SIDE CART (SSC), AND ADJUSTED THE EFFECT; THE SURGEON WAS ABLE TO USE THE FORCETRIAD GENERATOR AND PROCEED WITH THE SURGICAL TASK. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE REPORTED ERROR OCCURRED APPROXIMATELY 30 MINUTES INTO THE PROCEDURE. WHILE THE OTHERS WERE BUSY CONNECTING THE FORCETRIAD GENERATOR TO THE SYSTEM, THE SURGEON CONTINUED WITH THE SYNCHROSEAL INSTRUMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2395059 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-19 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES