BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS

    MDR report key: 1981371 · Received January 18, 2011

    Report

    Report Number
    1981371
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 16, 2011
    Report Date
    January 18, 2011
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    LS1020 LIGASURE DEVICE WAS IN USE. THE TEETH WERE STICKING TO TISSUE, AND THE JAW OF DEVICE WOULD NOT RE-SEPARATE. DEVICE WOULD ALSO DISCHARGE BY ITSELF WITHOUT PROMPT FROM USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HAND SWITCHING SEALER GEI COVIDIEN VALLEYLAB * S0H0001

    Patients

    Seq Age Sex Outcome Treatment
    1 *