BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC LINEAR CUTTER RELOAD, 60MM BLUE

    MDR report key: 1180826 · Received September 23, 2008

    Report

    Report Number
    2532140-2008-00069
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 23, 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 ROOT CAUSE OF THE ISSUE WAS AN IMPROPERLY SEATED RELOAD BY THE USER.

    Description of Event or Problem · 1

    TWO UNFORMED STAPLES WERE NOTED STUCK INSIDE THE CARTRIDGE. THE TISSUE WAS STUCK TO THE STAPLES AND HAD TO BE REMOVED.

    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-000270

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK