BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18944513 · Received March 20, 2024

    Report

    Report Number
    2955842-2024-12656
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    February 27, 2024
    Report Date
    February 27, 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
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE ERBE INTEGRATED ELECTRO SURGICAL UNIT (IESU) TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS WAS CONFIRMED AND REPRODUCED. THE IESU WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. ON STARTUP, THE IESU DISPLAYED A C-34 ERROR. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THE ERBE INTEGRATED ELECTRO SURGICAL UNIT (IESU) FAULTED TOWARDS THE END OF THE CASE. THE SURGEON WAS ABLE TO FINISH CASE ROBOTICALLY. THE TSE REVIEWED LOGS AND FOUND ERROR C-34 AND M-11 ON ERBE IESU. PRIOR TO CONTACTING THE TSE, THE CUSTOMER POWER CYCLED THE ERBE IESU, BUT ISSUE PERSISTED. THE CUSTOMER CONNECTED ENERGY ACTIVATION CABLE TO SPARE GENERATOR TO RESOLVE THE REPORTED ISSUE. THE ISI REP. CONTACTED THE TSE AND REPORTED THE ERBE IESU HAD A C-00 ERROR. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE PERFORMED WAS HYSTERECTOMY. THE SYSTEM DID INITIALLY POWER ON WITHOUT ERRORS. THE PROCEDURE WAS COMPLETED WHEN THE ERBE IESU STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047491 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DA VINCI INSTRUMENTS AND ACCESSORIES.