BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC LINEAR CUTTER RELOAD, 60MM GREEN

    MDR report key: 1082672 · Received July 23, 2008

    Report

    Report Number
    2532140-2008-00051
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 3, 2008
    Manufacturer
    POWER MEDICAL INTERVENTIONS
    Product Code
    GDW
    PMA / PMN Number
    K052415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PLCR60G HAD 5 STAPLES JAMMED ON THE RIGHT AND LEFT OUTER EDGES OF THE RELOAD. THERE WAS NO DAMAGE NOTED ON THE RELOAD THAT WOULD CAUSE THIS MALFUNCTION. THIS ISSUE WILL BE MONITORED TO FURTHER INVESTIGATE THE ROOT CAUSE AND TREND TO DETERMINE IF A CORRECTIVE ACTION IS WARRANTED.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, WHILE USING AN I60S AND PLCR60G AFTER FIRING, THE RELOAD STUCK TO TISSUE AND MALFORMED STAPLES WERE OBSERVED IN THE STAPLE LINE. WHILE REMOVING THE DEVICE ONE STAPLE THAT WAS CLOSED ON TISSUE OPENED UP AND REMAINED IN THE RELOAD. A BOVIE WAS USED TO GAIN ANASTAMOSIS AND SUTURE USED TO REPAIR LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC LINEAR CUTTER RELOAD, 60MM GREEN STAPLE, IMPLANTABLE GDW POWER MEDICAL INTERVENTIONS PM-000277

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR INTELLIGENT 60 MM STRAIGHT ENDOSCOPIC LINEAR| CUTTER (I60S)