BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1024236 · Received March 27, 2008

    Report

    Report Number
    1717344-2008-00114
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Report Date
    February 29, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE EVAL 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. 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 ALSO FOUND THAT IF THE JAWS ARE NOT CLEANED AS INSTRUCTED IN THE IFU, ESCHAR CAN BUILDUP 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. A COPY OF THIS HOTLINE BULLETIN HAS BEEN SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE JAWS OF THE LIGASURE ATLAS WOULD NOT OPEN DURING A PROCEDURE. THE SURGEON USED ANOTHER DEVICE TO OPEN IT. THERE WAS NO PT INJURY DUE TO THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (US SURGICAL) U7C04K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK