BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 1894747 · Received November 5, 2010

    Report

    Report Number
    1717344-2010-00793
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 24, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED 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 DEVICE ACTIVATED WHEN THE DOCTOR CLOSED THE JAWS EVEN THOUGH THE ACTIVATION BUTTON WAS NOT PRESSED. THIS CAUSED A REGRASP ALERT. 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) 191636

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK