BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 1953898 · Received December 15, 2010

    Report

    Report Number
    1717344-2010-00954
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 19, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2010. THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, INTERMITTENTLY DURING A HYSTERECTOMY, WHEN THE DEVICE WAS SHUT, IT ACTIVATED WITHOUT THE ACTIVATION BUTTON BEING PUSHED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 193248

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK