BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC LINEAR CUTTER RELOAD, 60MM BLUE

    MDR report key: 1213859 · Received October 22, 2008

    Report

    Report Number
    2532140-2008-00084
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 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

    UPON EXAMINATION IN TESTING LAB, ONE STAPLE WAS NOTED TO BE JAMMED IN THE RELOAD. THE RETENTION POSTS WERE NOTED TO BE UNDAMAGED. THE ROOT CAUSE FOR THE ISSUE IS UNKNOWN. ROOT CAUSE: THE ROOT CAUSE FOR THE RANDOM MALFORMS COULD NOT BE DETERMINED. THE ROOT CAUSE FOR THE RELOADS NOT BEING RECOGNIZED COULD NOT BE DETERMINED. ACTIONS: THESE ISSUES WILL BE MONITORED TO FURTHER INVESTIGATE THE ROOT CAUSES AND TRENDED TO DETERMINE IF CORRECTION ACTIONS ARE WARRANTED.

    Description of Event or Problem · 1

    AFTER THE SURGEON FIRED A DEVICE, TWO OR THREE UNDERFORMED STAPLES WERE NOTED, STUCK IN THE CARTRIDGE. A DEFECT IN THE STAPLE LINE WAS NOTED. THE SURGEON PLACED A SUTURE IN THE TISSUE TO CORRECT THE DEFECT 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