BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21281403 · Received January 31, 2025

    Report

    Report Number
    2955842-2025-01045
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 13, 2025
    Report Date
    January 14, 2025
    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
    MO, 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). 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 A SYSTEM AND WAS RUN IN NORMAL MODE. M-02-3/1-07 ERRORS DID OCCUR AT STARTUP. THE IESU HAS NO SIGNIFICANT SCRATCHES OR DENTS. THE FRONT BEZEL WAS IN DECENT CONDITION. E.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) WHILE IN A PROCEDURE TO REPORT MULTIPLE GENERATOR ISSUES DURING USE. THE CUSTOMER INFORMED THE TSE THAT MONOPOLAR AND BIPOLAR ENERGY WAS INTERMITTENT, AND THEY KEPT GETTING A M-02 ERROR THAT KEEP RETURNING. THE TSE CONFIRMED ERROR 25913 (M-02) ERRORS IN THE SYSTEM LOGS, POINTING TO THE GENERATOR. THE TSE ADVISED THE CUSTOMER THAT THE REPORTING M-02 ERRORS WILL LIKELY CONTINUE TO RETURN, AND A BACKUP ENERGY DEVICE WOULD BE RECOMMENDED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493830 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A 00886874110898

    Patients

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