BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 1904210 · Received November 15, 2010

    Report

    Report Number
    1717344-2010-00824
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 19, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSTRUMENT INADVERTENTLY ACTIVATED WHILE CLOSING THE JAWS OF THE DEVICE. 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) 190307

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK