BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1033007 · Received April 21, 2008

    Report

    Report Number
    1717344-2008-00156
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Report Date
    March 26, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT ONE OF THE ELECTRODES ON THE JAWS OF THE LIGASURE ATLAS HANDPIECE DETACHED DURING USE. THE ELECTRODE FELL INTO THE PT CAVITY AND WAS RETRIEVED.

    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) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK