BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 18081387 · Received November 6, 2023

    Report

    Report Number
    2955842-2023-20052
    Event Type
    Injury
    Date Received
    November 6, 2023
    Date of Event
    September 26, 2023
    Report Date
    October 11, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A DISLODGED MOLDED INSULATOR. THE MOLDED INSULATOR WAS NOT ATTACHED TO THE GRIP OF THE INSTRUMENT. THERE WAS NO PHYSICAL DAMAGE TO THE MOLDED INSULATOR AND NO PIECES WERE FOUND MISSING. THE CONDUCTOR WIRE WAS STICKING OUT BUT HAD NO DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CLAMP FROM THE FORCE BIPOLAR INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED IN THE SAME CASE. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338373 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K11230706 0254 00886874120767

    Patients

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