BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3983214 · Received June 27, 2014

    Report

    Report Number
    1717344-2014-00559
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    June 1, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 JAWS OF THE INCIDENT DEVICE WERE STUCK SHUT. THE KNIFE IS TRAPPED AND CONTAINED WITHIN THE JAWS, WHICH KEPT THE JAWS FROM OPENING. THIS CAN OCCUR WHEN THE BLADE IS EXTENDED AND THE JAWS ARE NOT COMPLETELY CLOSED. THIS ALLOWS THE KNIFE TRACK TO OPEN TOO WIDE AND THE BLADE MOVES OUT OF ITS TRACK. THE IFU CAUTIONS TO CONFIRM THAT THE JAWS HAVE REACHED THE CLOSED POSITION AND ARE LOCKED BEFORE ACTIVATING THE CUTTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE JAW WOULD NOT OPEN WHILE NOT ON PT TISSUE DURING A LAPAROSCOPIC COLORECTAL PROCEDURE. THERE WAS NO INJURY TO THE PT. THE DEVICE WAS RETURNED TO COVIDIEN AND VISUAL INSPECTION DISCOVERED THAT THE CLEAR INSULATION WAS MISSING. THE CUSTOMER REPORTED THAT NOTHING FELL INTO THE PT'S CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378407 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYS GEI COVIDIEN LP 32560008X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK