BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 20CM

    MDR report key: 1264724 · Received November 14, 2008

    Report

    Report Number
    1717344-2008-00520
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 16, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE INCIDENT DEVICE REVEALED TISSUE IN-BETWEEN THE JAWS. TESTS FOR RESISTANCE, JAW GAP AND JAW SPLAY WERE WITHIN THE ALLOWED RANGE. THE DEVICE WAS TESTED ON SIMULATED TISSUE FOR PROPER ACTIVATION AND KNIFE FUNCTION WITH ACCEPTABLE RESULTS. THERE IS A NOTICE IN THE INSTRUCTIONS FOR USE (IFU) THAT STATES, "DO NOT TURN THE ROTATION WHEEL WHEN THE HANDLE IS LATCHED. PRODUCT DAMAGE MAY OCCUR. THE JAWS MAY LOCK IN THE CLOSED POSITION." ADDITIONALLY, COVIDIEN LP (FORMERLY VALLEYLAB) HAS FOUND THAT IF THE JAWS ARE NOT CLEANED AS INSTRUCTED IN THE IFU, ESCHAR CAN BUILD UP AND CAUSE THE JAWS TO STICK TO THE SEALED TISSUE. COVIDIEN LP (FORMERLY VALLEYLAB) HAS ISSUED A HOTLINE BULLETIN TO INFORM CUSTOMERS ON HOW TO AVOID TISSUE BUILDUP THAT CAN LEAD TO STICKING.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE DEVICE STUCK ON TISSUE AND HAD TO BE CUT OUT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 20CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (US SURGICAL) U8A117K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK