BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60MM STRAIGHT ENDOSCOPIC LINEAR CUTTER

    MDR report key: 1063550 · Received June 19, 2008

    Report

    Report Number
    2532140-2008-00032
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    POWER MEDICAL INTERVENTIONS
    Product Code
    GDW
    PMA / PMN Number
    K071708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE SHORT IN THE TRANSISTOR IS UNK. THE TRANSISTORS ARE BEING REPLACED. A CORRECTIVE ACTION HAS BEEN UNDERTAKEN TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    WHEN THE JAWS OF THE I60 WERE CLOSED ON TISSUE DURING A LEFT COLECTOMY PROCEDURE, THE DEVICE LOST POWER: THE BUTTONS WERE INACTIVE AND THE LIGHTS WERE NOT ILLUMINATED. THE I60 WAS CUT OUT OF THE PT, AND THE PROCEDURE WAS COMPLETED BY USE OF ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 60MM STRAIGHT ENDOSCOPIC LINEAR CUTTER STAPLER, IMPLANTABLE GDW POWER MEDICAL INTERVENTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR ENDOSCOPIC LINEAR CUTTER RELOAD| 60MM BLUE (PLCR60B)