BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21932136 · Received April 30, 2025

    Report

    Report Number
    2955842-2025-17487
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 8, 2025
    Report Date
    April 8, 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
    CA, 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 WENT ON-SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL INC. (ISI) RECEIVED THE IESU FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND REMOTEFE COULD NOT CONFIRM THE FAULT THAT OCCURRED IN THE FIELD. VISUAL INSPECTION FOUND NO SIGNIFICANT SCRATCHES OR DENTS. THE FRONT BEZEL IS IN DECENT CONDITION. THE U-02 ERROR OCCURRED DURING STARTUP OF THE ERBE WHICH WAS PLACED ONTO THE GOLDEN SYSTEM AND WAS RUN IN NORMAL MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SERVICE ENGINEER (TSE) FOR PHONE ASSISTANCE REGARDING THE EBRE EXHIBITING U-02 ERRORS. PRIOR TO TSE BEING CALLED THE CUSTOMER REBOOTED THE INTEGRATED SURGICAL ELECTRICAL SURGICAL UNIT (IESU) SEVERAL TIMES WITHOUT CHANGE. TSE REQUESTED FOR A HARD REBOOT ON THE IESU AND THE REPORTED COMPLAINT REMAINED. THE CUSTOMER WAS INFORMED THAT HE IESU WAS NOT AVAILABLE; SINCE REBOOTING WAS THE ONLY OPTION FOR TROUBLESHOOTING FOR THE REPORTED SYSTEM ERROR. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222515 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-28 N/A 00886874110898

    Patients

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