BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17093801 · Received June 8, 2023

    Report

    Report Number
    2955842-2023-16090
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Date of Event
    August 20, 2021
    Report Date
    August 20, 2021
    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
    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 COMPLAINT. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) [ERBE] TO RESOLVE THE ISSUE(S). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE ERBE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT, "ACTIVATION IS INTERRUPTED; U-02 ERROR." FA INSTALLED AND TESTED THE UNIT ON AN IN-HOUSE SYSTEM AND RAN IN NORMAL MODE. FA NOTED ERROR(S) C-00/U-02 WERE PRESENT IN THE ERROR LOG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED ERROR(S) U-02 ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) [ERBE]. THE CUSTOMER WAS ABLE TO CLEAR THE ERRORS; HOWEVER, THE ERRORS RETURNED. PRIOR TO CALLING, THE CUSTOMER SWAPPED OUT THE VISION SIDE CART (VSC) AND PROCEEDED WITH THE CASE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) STATED THERE WERE MULTIPLE ERROR(S) U-02 OBSERVED IN THE SYSTEM LOGS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550884 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A 00886874110898

    Patients

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