BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3192522 · Received June 19, 2013

    Report

    Report Number
    1717344-2013-00430
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    April 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE KNIFE DID NOT ADVANCE WHEN THE TRIGGER WAS ACTIVATED AND IT WAS FOUND THAT THE KNIFE WAS HITTING THE BACK OF THE BLUE JAW SEAL PLATE. THE KNIFE EDGE WAS DAMAGED WHEN IT CONTACTED THE SEAL PLATE. THE KNIFE WAS STILL WITHIN THE JAWS, BUT THE WEBBING WAS PROTRUDING FROM THE HINGE AREA AND IS NOT SHARP. THE KNIFE HITTING THE SEAL PLATE CAUSED THE WEBBING TO PROTRUDE. A PRODUCTION SCREENING FIXTURE AND A DEEPER KNIFE SLOT IN THE JAW WERE PUT IN PLACE TO HELP MITIGATE THE OCCURRENCE OF THE KNIFE HITTING THE BACK OF THE SEAL PLATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DID NOT CUT. THE DEVICE WAS RETURNED AND VISUAL INSPECTION CONFIRMED THAT THE KNIFE WEBBING WAS PROTRUDING FROM THE HINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278965 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 247539X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK