BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON HARMONIC ACE

    MDR report key: 2926578 · Received January 18, 2013

    Report

    Report Number
    2926578
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 18, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    SURGEON TOOK THE DEVICE AND INSERTED THE TROCAR DOWN INTO THE ABDOMINAL CAVITY AND BEGAN TO SQUEEZE THE HANDLE ON THE SHEARS AND ONE EDGE OF THE SHEARS FLIPPED BACKWARDS INSTEAD OF FORWARD AND BECOMING FLUSH WITH THE OTHER BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27231 ETHICON HARMONIC ACE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER SUSTAINABILITY SOLUTIONS * 2247879

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR