BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC LINEAR CUTTER RELOAD, 60MM BLUE

    MDR report key: 1202073 · Received October 16, 2008

    Report

    Report Number
    2532140-2008-00078
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    POWER MEDICAL INTERVENTIONS
    Product Code
    GDW
    PMA / PMN Number
    K052415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO EVALUATION COULD BE PERFORMED, SINCE THE DEVICE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    AFTER A FIRING OF A STAPLES WERE MALFORMED AND SOME WERE STUCK IN THE RELOAD. THE KNIFE DID NOT CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC LINEAR CUTTER RELOAD, 60MM BLUE STAPLE, IMPLANTABLE GDW POWER MEDICAL INTERVENTIONS PM-000261

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR