BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3970196 · Received April 29, 2014

    Report

    Report Number
    1717344-2014-00377
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 25, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE KNIFE IS TRAPPED AND CONTAINED WITHIN THE JAWS, WHICH KEPT THE JAWS FROM OPENING EASILY. 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 BLADE MOVES OUT OF ITS TRACK. MORE FREQUENT CLEANING COULD HAVE ALSO REDUCED THE DIFFICULTY ACTIVATING THE KNIFE. THE IFU CAUTIONS TO CONFIRM THAT THE JAWS HAVE REACHED THE CLOSED POSITON AND ARE LOCKED (THE HANDLE IS LATCHED) BEFORE ACTIVATING THE CUTTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE KNIFE BLADE WAS STICKING AND THE DEVICE WAS HARD TO OPEN AT TIMES. THERE WAS NO INJURY TO THE PATIENT. THE DEVICE WAS RETURNED TO COVIDIEN AND VISUAL INSPECTION DISCOVERED THAT THE CLEAR INSULATION WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255792 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 40300211X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK