BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19198409 · Received April 26, 2024

    Report

    Report Number
    2955842-2024-13695
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 2, 2024
    Report Date
    April 2, 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
    003

    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 ELECTRO SURGICAL UNIT (IESU) UNIT FOR INTERMITTENT ISSUES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE IESU INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE REPORTED ISSUE WAS CONFIRMED AND REPRODUCED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARAESOPHAGEAL HIATAL HERNIA SURGICAL PROCEDURE, THE MONOPOLAR ENERGY WAS NOT WORKING ON THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) OR ERBE GENERATOR. THE CLINICAL SALES REPRESENTATIVE (CSR) INFORMED FIELD SERVICE ENGINEER (FSE) THAT THE ERBE WAS NOT FIRING ON MONOPOLAR. THE CUSTOMER HAD TO CONNECT TO THE FORCE TRIAD GENERATOR. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039352 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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