BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18222233 · Received November 28, 2023

    Report

    Report Number
    2955842-2023-20642
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    November 3, 2023
    Report Date
    November 3, 2023
    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
    ID, 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. FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE REPORTED C-34 ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND RUN IN NORMAL MODE. THE IESU FAILURE WAS CONFIRMED AND REPRODUCED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL COLORECTAL SURGICAL PROCEDURE, THE ERBE SCREEN DISPLAYED A MESSAGE OF INTERRUPTED ACTIVATION AND ERROR C-34. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) CONFIRMED MULTIPLE ERRORS C-34 IN THE ERROR LOGS. THE TSE RECOMMENDED TRYING TO REBOOT THE ERBE GENERATOR. THE CUSTOMER STATED THE ENERGY WAS WORKING BUT THEY WERE GETTING C-34 ERROR ALMOST EVERY MINUTE. THE TSE EXPLAINED THAT THE CUSTOMER COULD ALSO SWAP THE VISION SIDE CART (VSC) WITH ANOTHER VSC OR USE A VALLEY LAB FORCE TRIAD AS AN ALTERNATE ENERGY METHOD. THE CUSTOMER STATED THEY WERE CONTINUING WITH THE CASE AND WOULD TRY A REBOOT ON THE ERBE WHEN THEY HAD A CHANCE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512195 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-28 N/A 00886874110898

    Patients

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