BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 2944140 · Received January 30, 2013

    Report

    Report Number
    1717344-2013-00052
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    October 12, 2012
    Report Date
    January 9, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. ALSO NOTED ON THE DEVICE WAS DAMAGE TO THE CLEAR INSULATION. THE INSTRUCTIONS FOR USE (IFU) STATES CAREFULLY INSERT AND WITHDRAW THE INSTRUMENT FROM CANNULAE TO AVOID POSSIBLE DAMAGE TO THE DEVICES AND/OR INJURY TO THE PATIENT. USE THE APPROPRIATELY SIZED TROCAR TO ALLOW FOR EASY INSERTION AND EXTRACTION OF THE INSTRUMENT. FAILURE TO DO SO MAY IMPACT THE INTEGRITY OF THE FLEXIBLE INSULATION. TROCAR CANNULAE WITH HARD, NON-BEVELED OPENINGS MAY CAUSE THE FLEXIBLE INSULATION TO RETRACT, WHICH MAY COMPROMISE THE INSULATION. IF RETRACTION OCCURS, THE INSTRUMENT MUST BE DISCARDED. INJURY HAS RARELY BEEN REPORTED WITH THESE COMPLAINTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CLEAR INSULATION KEPT SLIDING BACK ON ITSELF DURING THE CASE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO INJURY TO THE PATIENT. THE DEVICE WAS RETURNED FOR INVESTIGATION AND VISUAL INSPECTION DISCOVERED THAT THE WEBBING WAS PROTRUDING FROM THE HINGE AREA OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41695 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 237072X

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR