BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3070987 · Received April 1, 2013

    Report

    Report Number
    1717344-2013-00241
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 15, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 BROKEN AND PROTRUDING FROM THE HINGE AREA. THE WEBBING MAY HAVE BROKEN IF FORCE WAS APPLIED TO THE TRIGGER AFTER THE KNIFE CONTACTED THE SEAL PLATE. 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 KNIFE BLADE JAMMED DURING THE PROCEDURE. THE SURGEON MANUALLY OPENED THE DEVICE OFF THE PATIENT'S TISSUE AND OPENED ANOTHER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE DEVICE WAS RECEIVED AT COVIDIEN AND VISUAL INSPECTION DISCOVERED THE WEB PROTRUDING FROM THE HINGE OF THE JAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131295 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 244998X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK