BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS ACMI, INC

    MDR report key: 1410845 · Received June 24, 2009

    Report

    Report Number
    MW5011750
    Event Type
    Malfunction
    Date Received
    June 24, 2009
    Date of Event
    June 24, 2009
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRODUCT DID NOT WORK WHEN USED IN PROCEDURE. IT LOOKS LIKE THE RATCHET DID NOT WORK PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYRUS ACMI, INC PKS CUTTING FORCEPS W/ATTACHED CORD, 5MM, STEM GEI GYRUS ACMI INC. 920005PK 88320CB

    Patients

    Seq Age Sex Outcome Treatment
    1 *