BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 4203551 · Received September 17, 2014

    Report

    Report Number
    1717344-2014-00821
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 16, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 DEVICE WAS ACTIVATED ON SIMULATED WITH ACCEPTABLE RESULTS AND A VISUAL SEAL EFFECT WAS OBSERVED. ADDITIONAL FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED DEVICE WITH PORCINE KIDNEY TISSUE. MULTIPLE SEALS ON VARIOUS SIZE VESSELS WERE MADE. ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A SLEEVE GASTRECTOMY ALARMS WERE PROVIDED BY THE GENERATOR AND THE DEVICE WOULD NOT WORK. A NEW INSTRUMENT OF THE SAME TYPE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE THERE WAS NO PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATED AND A VISUAL INSPECTION REVEALED THAT THE INSULATION ON THE DEVICE WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575382 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 41280032X

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR