BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19522368 · Received June 12, 2024

    Report

    Report Number
    2955842-2024-15650
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 14, 2024
    Report Date
    May 14, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT AND REPLACED THE GENERIC CART CONTROLLER (GCC) BOARD. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE GCC BOARD AND COMPLETED THE DEVICE EVALUATION. THE UNIT WAS ANALYZED, AND FAILURE ANALYSIS CONFIRMED AND REPLICATED THE REPORTED ISSUE BY INSTALLING THE GCC BOARD INTO A SYSTEM. THE UNIT FAILED. THERE WAS NO POWER ON THE SURGEON SIDE CART. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE SYSTEM KEPT FAULTING OUT WHEN THE SECOND CONSOLE WAS HOOKED UP. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND COMMUNICATION ERRORS AND 316 ERRORS. THE TSE ASKED THE CUSTOMER IF THEY HAD A SIMULATOR ON THE CONSOLE, BUT NEITHER CONSOLE HAD A SIMULATOR. THE CUSTOMER DISCONNECTED THE SECOND CONSOLE AND RESTARTED THE SYSTEM, AND IT CAME UP ERROR-FREE. THE CUSTOMER WAS LEAVING THE SECOND CONSOLE DISCONNECTED FOR THE CASE. NO TROUBLESHOOTING WAS DONE AT THE TIME OF THE CALL AS THE REPORTER WAS NOT IN THE ROOM AT THE TIME OF THE REPORT. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373430 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-17 N/A 00886874110744

    Patients

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