BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO

    MDR report key: 2240929 · Received September 3, 2011

    Report

    Report Number
    2240929
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENSEAL TRIO WAS BEING USED TO TAKE DOWN PELVIC ADHESIONS AND AFTER ONE HOUR OF USE, THE ANVIL BROKE WITHIN THE JAW OF THE INSTRUMENT; IT LIFTED OFF. NOTHING BROKE OFF INSIDE OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II * H4409E

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR