BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1034054 · Received April 24, 2008

    Report

    Report Number
    1717344-2008-00120
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 14, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATIONS HAVE BEEN ABLE TO DUPLICATE THIS FAILURE MODE BY CLAMPING ON LARGE, RIGID TISSUE. THE INSTRUCTIONS FOR USE FOR THIS DEVICE WARN AGAINST OVERFILLING THE JAWS OF THE INSTRUMENT BECAUSE IT MAY COMPROMISE THE CUTTING FUNCTION. THE IFU ALSO STATES TO CONFIRM THE JAWS HAVE REACHED THE CLOSED POSITION (TIPS OF THE JAWS NO MORE THAN 2 MM APART) BEFORE ACTIVATING THE CUTTER. OTHERWISE, THE CUTTER MAY NOT SECURELY STAY WITHIN THE GUIDING TRACK OF THE JAWS.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A HYSTERECTOMY, THE JAWS OF THE LIGASURE IMPACT LOCKED SHUT OUTSIDE OF THE SURGICAL FIELD. THIS HAPPENED TO TWO DEVICES IN THE SAME PROCEDURE. EVAL OF THE RETURNED DEVICES ON MARCH 28, 2008 FOUND THE JAWS OF THE DEVICE TO BE CLOSED ON THE INTEGRATED CUTTER. THE CUTTER IS PROTRUDING BEYOND THE PERIMETER OF THE CLOSED JAWS, WHICH COULD POSE A HAZARD TO THE PT OR USER. THE SECOND DEVICE FROM THIS PROCEDURE IS BEING REPORTED ON MFR REPORT # 1717344-2008-00119.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 133618

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK