BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER SUSTAINABILITY SOLUTIONS

    MDR report key: 2599743 · Received May 30, 2012

    Report

    Report Number
    MW5025631
    Event Type
    Malfunction
    Date Received
    May 30, 2012
    Date of Event
    May 22, 2012
    Report Date
    May 30, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP OF THE INACTIVE BLADE REPROCESSED HARMONIC ACE USED DURING SURGERY HAD COATING PEELING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER SUSTAINABILITY SOLUTIONS HARMONIC ACE SHEARS, 5.5 DIA ERG HANDLE, CURVED BLADE LFL STRYKER SUSTAINABILITY SOLUTIONS ACE36E 1930651

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR