BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3823706 · Received May 1, 2014

    Report

    Report Number
    1717344-2014-00391
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    October 14, 2013
    Report Date
    April 25, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE JAWS WERE NOT JAMMED SHUT. THE JAWS OPENED AND CLOSED NORMALLY WHEN THE HANDLE WAS ACTIVATED. THE CLEAR INSULATION WAS DAMAGED. THE DEVICE FAILED HIPOT TESTING. THE IFU STATES TO PREVENT DAMAGE TO THE FLEXIBLE INSULATION PROXIMAL TO THE JAWS, CONFIRM THE HANDLE IS FULLY CLOSED PRIOR TO INSERTION INTO AND EXTRACTION FROM THE CANNULA. USE THE APPROPRIATELY SIZED CANNULA TO ALLOW FOR EASY INSERTION AND EXTRACTION OF THE INSTRUMENT. FAILURE TO DO SO MAY IMPACT THE INTEGRITY OF THE FLEXIBLE INSULATION. CANNULAS 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. DO NOT ATTEMPT TO CLEAN THE FLEXIBLE INSULATION. CLEANING MAY DAMAGE INSULATION. SHAVED JAW FLAGS HAVE BEEN PUT IN PLACE TO HELP MITIGATE THE CLEAR INSULATION BEING COMPROMISED. THIS DEVICE WAS MANUFACTURED PRIOR TO THAT CHANGE. THE KNIFE WAS HITTING THE BACK OF THE BLUE JAW SEAL PLATE. THIS CAN HAPPEN WHEN THE USER PLACES EXCESSIVE TENSION ON THE JAWS, FORCING THEM OUT OF ALIGNMENT. THE IFU CAUTIONS THE USER TO NOT TURN THE ROTATION WHEEL WHEN THE HANDLE IS FULLY CLOSED AND LATCHED. PRODUCT DAMAGE MAY OCCUR. DO NOT APPLY FORCE TO THE SHAFT OF THE INSTRUMENT CAUSING TENSION OF BOWING AS THIS COULD MAKE THE KNIFE DIFFICULT TO DEPLOY AND THE TRIGGER MAY NOT RETURN TO ITS NORMAL POSITION. WHEN THE KNIFE CONTACTED THE BACK OF THE SEAL PLATE, THE TRIGGER WAS FORCED AND THIS CAUSED THE WEBBING TO PROTRUDE. THE WEBBING WAS NOT SHARP. THE IFU STATES TO GENTLY PULL THE CUTTING TRIGGER TO ENGAGE THE CUTTING MECHANISM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE JAWS WOULD NO LONGER OPEN DURING THE PROCEDURE. THE JAWS WERE NOT ON TISSUE AT THE TIME. A SECOND DEVICE WAS USED AND THERE WAS NO INJURY TO THE PATIENT. THE DEVICE WAS RETURNED TO COVIDIEN AND VISUAL INSPECTION DISCOVERED THAT THE CLEAR INSULATION WAS DAMAGED AND THE WEBBING WAS PROTRUDING FROM THE HINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261038 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 235390X

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR