BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL

    MDR report key: 2954140 · Received January 31, 2013

    Report

    Report Number
    2954140
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE INSTRUMENT AND MET WITH RESISTANCE. THE HANDLE ALSO LOCKED. THE HANDLE WAS PULLED OUT AND THE JAWS WERE BROKEN AS WAS A SMALL PORTION OF THE BLADE. ALL PIECES ARE BELIEVED TO BE ACCOUNTED FOR. RADIOLOGY STUDIES DONE TO CONFIRM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPARSCOPIC OOPHORECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41905 ENSEAL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, INC. * J4AV5Y

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR NO OTHER THERAPIES