BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC LINEAR CUTTER RELOAD, 60MM BLUE

    MDR report key: 1190582 · Received October 6, 2008

    Report

    Report Number
    2532140-2008-00081
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    POWER MEDICAL INTERVENTIONS
    Product Code
    GDW
    PMA / PMN Number
    K052415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RELOAD HAS AN IMPRESSION ON THE TISSUE BUMPS INDICATING THE RELOAD WAS CLAMPED ON AN OBSTRUCTION.

    Description of Event or Problem · 1

    UPON FIRING A PLCR60B, THE TISSUE STUCK TO THE RELOAD AND UNFORMED STAPLES WERE NOTED IN THE TISSUE AFTER FIRING. THE SURGEON USED A GRASPER TO REMOVE THE TISSUE AND A DEFECT WAS OBSERVED IN THE STAPLE LINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK