BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20404403 · Received October 8, 2024

    Report

    Report Number
    2955842-2024-20308
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 13, 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
    MI, US
    Reporter Occupation
    NURSE
    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 EVENT. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE U-02 ERROR WAS CONFIRMED AND REPLICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION SURGICAL PROCEDURE, THE ERBE GENERATOR HAD A U-02 ERROR AFTER PLUGGING IN THE GROUNDING PAD. THE TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE CALLER THROUGH HARD POWER CYCLING AND REMOVING EXTERNAL FOOT PEDAL CABLES WHICH DID NOT RESOLVE THE ISSUE. TSE ASKED IF THEY HAVE A BACKUP GENERATOR, CALLER FOUND ENERGY CABLE FOR BACKUP GENERATOR AND WILL CONTINUE, SHOULD BACKUP GENERATOR NOT WORKING, THEY WILL TRY TO SWAP VISION TOWERS. INTUITIVE SURGICAL FOLLOWED UP WITH THE CUSTOMER AND GATHERED ADDITIONAL INFORMATION. THE ISSUE WAS IDENTIFIED DURING THE PROCEDURE. PORTS WERE PLACED PRIOR TO THE ISSUE BEING IDENTIFIED. THE CASE WAS COMPLETED ROBOTICALLY, WITH THE USE OF A VALLEY LAB ANCILLARY BOVIE MACHINE. THIS BOVIE MACHINE WAS ROUTED TO THE VISION TOWER AND USED IN PLACE OF THE ERBE GENERATOR ON THE VISION TOWER. THERE WAS NO INJURY TO THE PATIENT. TO RESOLVE THE REPORTED ISSUE THE CUSTOMER RE-ROUTED THE ERBE GENERATOR TO AN ANCILLARY BOVIE MACHINE. SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. TECHNICAL SUPPORT WAS CONTACTED FOR TROUBLESHOOTING AND FULL TROUBLESHOOTING WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23000 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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