BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, INC. - REPROCESSED BY STRYKER

    MDR report key: 2803954 · Received October 16, 2012

    Report

    Report Number
    MW5027288
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 16, 2012
    Manufacturer
    STRYKER
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HARMONIC ACE SHEARS, ACE23E PAD MELTED DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. - REPROCESSED BY STRYKER HARMONIC ACE SHEARS, 5.5 DIA ERG HANDLE, CURVED BLADE LFL STRYKER ACE23E 2095637

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other