BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3970205 · Received April 29, 2014

    Report

    Report Number
    1717344-2014-00378
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Report Date
    April 25, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PART OF THE CLEAR INSULATION WAS MISSING. 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. THE DEVICE WAS ACTIVATED ON SIMULATED TISSUE WITH ACCEPTABLE RESULTS AND A VISUAL SEAL EFFECT WAS OBSERVED. THE SAMPLE FUNCTIONED NORMALLY WHEN ACTIVATED IN THE MONOPOLAR MODE AS WELL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT OPENING PROPERLY DURING A LAPAROSCOPIC COLECTOMY. THERE WAS NO INJURY TO THE PATIENT. THE DEVICE WAS RETURNED TO COVIDIEN AND VISUAL INSPECTION DISCOVERED THE CLEAR INSULATION WAS NO LONGER ATTACHED. THE SITE CONFIRMED THAT THE INSULATION DID NOT FALL INTO THE PATIENT ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255794 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 32900145X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK