BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JHOOK

    MDR report key: 19585054 · Received June 20, 2024

    Report

    Report Number
    MW5156449
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    June 17, 2024
    Report Date
    June 17, 2024
    Manufacturer
    U.S. SURGITECH, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    J-HOOK COATING STARTED COMING OFF WHILE IN USE. PERFORMED A LAPAROSCOPIC CHOLECYSTECTOMY. DURING THE PROCEDURE THE J-HOOK COATING BEGAN TO COME OFF WHILE THE SURGEON WAS USING. IT WAS DISCARDED AND A NEW J-HOOK WAS UTILIZED TO CONTINUE THE CASE. THERE WAS NO HARM TO THE PATIENT. US SURGICAL TECH; 790-104-535.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2178239 JHOOK ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI U.S. SURGITECH, INC. 790-104-535

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Other