BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3823702 · Received May 1, 2014

    Report

    Report Number
    1717344-2014-00392
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    March 3, 2014
    Report Date
    April 29, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLEAR INSULATION WAS NO LONGER ON THE DEVICE. 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 WERE NOT JAMMED SHUT. THE JAWS OPENED AND CLOSED NORMALLY WHEN THE HANDLE WAS ACTIVATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE JAWS WOULD NO LONGER OPEN AFTER SEALING. THEY WERE REMOVED FROM THE PT WITHOUT ADDITIONAL RESECTION OR TISSUE DAMAGE. THERE WAS NO INJURY TO THE PT. THE DEVICE WAS RETURNED TO COVIDIEN AND VISUAL INSPECTION DISCOVERED THAT THE CLEAR INSULATION WAS NO LONGER ON THE DEVICE. THE SITE HAD STATED THAT NOTHING FELL INTO THE PT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261014 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK