BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19581464 · Received June 21, 2024

    Report

    Report Number
    2955842-2024-15515
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 24, 2024
    Report Date
    May 24, 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
    TW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) TO RESOLVE THE REPORTED ISSUE. INTUITIVE SURGICAL, INC. (ISI) HAS COMPLETED THE EVALUATION OF THE IESU. THE REPORTED FAILURE (ERBE ERROR C-34) WAS CONFIRMED AND REPRODUCED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, AN ERROR C-34 OCCURRED ON THE INTEGRATED ELECTRO SURGICAL UNIT (IESU-ERBE). THE MONOPOLAR ENERGY WAS NOT FIRING. THE CUSTOMER TRIED TO POWER CYCLE THE ERBE, EXCHANGE THE MONOPOLAR INSTRUMENT CABLE, AND CHANGE THE MONOPOLAR PORT BUT THE ISSUE PERSISTED. THE TECHNICAL SERVICE ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO CONNECT A FORCETRIAD GENERATOR TO THE VISION SIDE CART (VSC). THE FORCETRIAD WAS NOT WORKING IN THE BEGINNING BUT THE ISSUE WAS RESOLVED BY DISCONNECTING THE BIPOLAR CABLE ON THE FORCETRIAD REAR PANEL. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED BY USING A FORCETRIAD GENERATOR. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281068 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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