BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18784519 · Received February 26, 2024

    Report

    Report Number
    2955842-2024-11362
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    November 23, 2023
    Report Date
    February 7, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874121511
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CURVED BIPOLAR DISSECTOR INSTRUMENT FOR FAILURE ANALYSIS. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION ENGAGEMENT, ELECTRICAL CONTINUITY AND ENERGY DELIVERY TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS AND THE GRIPS OPENED AND CLOSED PROPERLY. AS PART OF INVESTIGATION, INSPECTION FOUND A DAMAGED CONDUCTOR WIRE INSULATION AT THE DISTAL END. THE INTERNAL WIRES ARE EXPOSED. THE WIRES ARE CONTINUOUS AND NOT BROKEN. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY AND ENERGY DELIVERY TESTS. THERE WAS NO THERMAL DAMAGE AND NO MISSING MATERIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CURVED BIPOLAR DISSECTOR INSTRUMENT FAILED TO ACTIVATE BIPOLAR ENERGY. THE PROCEDURE WAS CONTINUED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102569 ENDOWRIST CURVED BIPOLAR DISSECTOR NAY INTUITIVE SURGICAL, INC 471344-17 K10230310 0114 00886874121511

    Patients

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