BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20762472 · Received November 22, 2024

    Report

    Report Number
    2955842-2024-22285
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    October 29, 2024
    Report Date
    October 29, 2024
    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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) ARRIVED ON SITE AND CONFIRMED VISION SIDE CART AND COMPONENTS WERE ON THE SAME SHARED CIRCUIT WITH 3RD PARTY DEVICES. FSE WORKED WITH CUSTOMER TO RELOCATE CARTS TO ISOLATED CIRCUITS, BUT VESSEL SEALER EXTEND INSTRUMENT AND ERBE GENERATOR WERE STILL SHARED WITH 3RD PARTY DEVICES. STAFF WILL DISCUSS WITH ENGINEERING REGARDING POSSIBLE CHANGES. CHARGE NURSE CONFIRMED THEY WILL CONTINUE USE OF SYSTEM IN CURRENT STATE WITH ERBE AND E-100 GENERATOR ON SURGE PROTECTORS ON SHARED CIRCUITS WITH MULTIPLE 3RD PARTY DEVICES. FSE CONFIRMED ON POWER UP U-02 ERROR WAS CONSTANT. FSE HAD ISSUES ISOLATING ERBE POWER CORD TO WALL OUTLET DUE TO LOCATION OF CART AND CUSTOMER ONLY USING SURGE PROTECTORS. THE FSE REPLACED THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU). SYSTEM TESTED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE IESU TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM VIA SYSTEM LOGS AND REPRODUCE THE REPORTED ISSUE WHEN THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE UNIT HAD NO SIGNIFICANT SCRATCHES OR DENTS. THE FRONT BEZEL WAS IN DECENT CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE THAT THE ERBE GENERATOR REPEATEDLY FAULTED WITH ERROR M-02 AND WOULD NOT PROVIDE ENERGY. A MESSAGE PRESENTED ADVISING TO CHECK THE ENERGY CABLES. THE CALLER TRIED NEW ENERGY CABLES, BUT THE ISSUE REMAINED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND CONFIRMED THE REPORTED ISSUE. THE TSE HAD THE CALLER VERIFY IF THE ERBE GENERATOR WAS PLUGGED INTO A POWER STRIP, OR DEDICATED OUTLET. THE CALLER CONFIRMED IT WAS A DEDICATED OUTLET. THE TSE WALKED THE CALLER THROUGH A POWER CYCLE OF THE ERBE, BUT UPON POWER UP THE UNIT FAULTED WITH A U-02 ERROR. THE TSE RECOMMENDED USING A FORCE TRIAD GENERATOR TO BYPASS THE ERBE. THE SURGEON ELECTED TO USE THE VESSEL SEALER EXTEND (VSE) INSTRUMENT IN THE E-100 GENERATOR. THE STAFF FINISHED UP THE CASE. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2599214 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES