BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1051930 · Received May 23, 2008

    Report

    Report Number
    1717344-2008-00226
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 6, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: MAY 23, 2008. EVALUATION OF THE RETURNED DEVICE ON MAY 6, 2008 FOUND THAT THE INTEGRATED CUTTER IS TRAPPED BETWEEN THE JAWS OF THE INSTRUMENT AND IS PROTRUDING BEYOND THE EDGE OF THE JAWS. 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 THE LIGASURE IMPACT WAS IN USE DURING A BOWEL RESECTION, THE HANDLE OF THE DEVICE WOULD NOT CLOSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK