BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGHT ANGLE LINEAR CUTTER, 45MM DLU

    MDR report key: 1180214 · Received September 29, 2008

    Report

    Report Number
    2532140-2008-00067
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    POWER MEDICAL INTERVENTIONS
    Product Code
    GDW
    PMA / PMN Number
    K012809
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER ANALYSIS, IT APPEARS THAT THE FIRE SIDE DRIVE CLIP OF THE RALC45 WAS BENT INWARDS. THIS MAY HAVE OCCURRED WHEN THE RALC45 WAS ATTACHED TO THE IDRIVE.

    Description of Event or Problem · 1

    A RALC45 DEVICE WAS CONNECTED TO AN IDRIVEC DEVICE. THE RALC DEVICE WAS CALIBRATED, POSITIONED, THEN CLOSED AND FIRED. A GRINDING NOISE WAS HEARD, AFTER FIRING SEQUENCE, THE SURGEON NOTED THAT THE TISSUE WAS PARTIALLY CUT AND THAT NO STAPLES WERE PLACED IN THE TISSUE. THE LEAK WAS CLOSED WITH SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGHT ANGLE LINEAR CUTTER, 45MM DLU STAPLE, IMPLANTABLE GDW POWER MEDICAL INTERVENTIONS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention