BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18156728 · Received November 16, 2023

    Report

    Report Number
    2955842-2023-20381
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    October 27, 2023
    Report Date
    October 27, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE CLEANED AND RESEATED THE BLUE FIBER CABLES TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA SURGICAL PROCEDURE, THE SURGEON LOST CONTROL OF ALL ARMS. THE SURGEON HEARD AN AUDIBLE BEEPING SOUND AND THEN LOST CONTROL OF ARMS 1 AND 3. THE SURGEON WAS ABLE TO REGAIN CONTROL OF ARM1, BUT WAS UNABLE TO REGAIN CONTROL OF ARM 3. THE CUSTOMER MOVED THE INSTRUMENT TO ARM 4 AND CONTINUED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) NOTED NO RELATED ERRORS AND THE CUSTOMER CONFIRMED THAT THERE WAS NO ERROR MESSAGE ON THE SCREEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153183 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-17 N/A 00886874110744

    Patients

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