BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 20CM

    MDR report key: 1220780 · Received October 31, 2008

    Report

    Report Number
    1717344-2008-00499
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: 10/30/2008. 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. WHILE THE EVALUATION OF THE INCIDENT DEVICE SHOWED THE DEVICE PERFORMS ACCORDING TO SPECIFICATION, TURNING THE ROTATION WHEEL WHILE THE HANDLE IS FULLY CLOSED CAN CAUSE THE JAWS TO LOCK SHUT. 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 DURING A HYSTERECTOMY, THE DEVICE JAWS LOCKED ON THE OVARIAN LIGAMENT AFTER APPROXIMATELY 13-15 SEALS. THE SURGEON REMOVED THE INSTRUMENT BY CUTTING IT OUT OF THE LIGAMENT. 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) N8D432K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK