BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18582668 · Received January 25, 2024

    Report

    Report Number
    2955842-2024-10642
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Date of Event
    January 3, 2024
    Report Date
    January 3, 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. THE FSE WAS ABLE TO REPRODUCE THE REPORTED ISSUE AND REPLACED THE ERBE GENERATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE ERBE GENERATOR TO PERFORM FAILURE ANALYSIS. THE UNIT WAS ANALYZED AND FOUND TO TRIGGER ERROR U-02 ON STARTUP WHEN BEING TESTED IN NORMAL MODE ON THE IN-HOUSE SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, AN "ACTIVATION HAS BEEN INTERRUPTED" MESSAGE OCCURRED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER VIEWED THE LOG AND FOUND ERROR U- 02 ON THE ERBE GENERATOR. THE CUSTOMER WAS ABLE TO COMPLETE CASE ROBOTICALLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016489 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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