BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 1894764 · Received November 5, 2010

    Report

    Report Number
    1717344-2010-00792
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 17, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED (B)(4) DEVICE WAS RETURNED FOR EVAL. SEALING FUNCTION WAS TESTED ON THE DEVICE AND SELF-ACTIVATION WAS CONFIRMED WHEN THE HANDLE WAS LATCHED. THE CAUSE OF THE SELF-ACTIVATION IS DUE TO AN EXTENDED TAB ON THE SWITCH COVER. COVIDIEN HAS IMPLEMENTED A NEW SWITCH COVER WITH A SHORTER TAB. THIS DEVICE WAS MFG PRIOR TO THIS CHANGE BEING IMPLEMENTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS ACTIVATING WITHOUT THE ACTIVATION BUTTON BEING PUSHED. THE DEVICE WAS NOT ON TISSUE AT THE TIME AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 190931

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK