BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19704779 · Received July 9, 2024

    Report

    Report Number
    2955842-2024-16794
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 14, 2024
    Report Date
    June 14, 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
    TX, 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 ISI FSE WENT ON SITE AND REPLACED INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED AND FOUND TO HAVE ERROR U-02 ON THE IESU. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE UNIT WILL BE RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR REPAIR. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION/FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED PLEURAL DECORTICATION SURGICAL PROCEDURE, THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THEY WERE GETTING AN INTEGRATED ELECTROSURGICAL UNIT (IESU) A U-02 ERROR FREQUENTLY. THE ISI TSE CONFIRMED THE U-02 ERROR IN THE LOGS. ISI TSE RECOMMENDED DOING A HARD REBOOT ON THE IESU TO SEE IF THE ERROR WOULD CLEAR. THE CUSTOMER PULLED THE POWER CABLE FROM THE IESU AND REBOOTED THE IESU 3 TIMES, BUT THE U-02 ERROR RETURNED AFTER EACH REBOOT. THE ISI TSE RECOMMENDED SWAPPING WITH THEIR OTHER VISION TOWER IF IT WAS AVAILABLE OR USING A VALLEY LAB FORCE TRIAD. THE SITE GOT VALLEY LAB FORCE TRIAD AND CONTINUED WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392050 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-44 N/A 00886874110898

    Patients

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