BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18673049 · Received February 8, 2024

    Report

    Report Number
    2955842-2024-11015
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    January 5, 2024
    Report Date
    January 25, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE INSULATION DAMAGE ON THE CONDUCTOR WIRE. THE INTERNAL WIRES WERE EXPOSED AS A RESULT. THE DAMAGE WAS LOCATED AT THE DISTAL END ON THE BIPOLAR YAW PULLEY. THE INSTRUMENT PASSED ELECTRIC CONTINUITY TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD FRAYED CABLES AT INSTRUMENT TIP. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER DID NOT KNOW WHICH PATIENT THIS INSTRUMENT WAS LAST USED ON. THE FRAYED CABLE WAS FOUND BY THE STERILE PROCESSING DEPARTMENT. THERE WAS NO REPORT OF ARCING OBSERVED. THERE WAS NO REPORT OF INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69330 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K11230817 0400 00886874119808

    Patients

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