BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 1961477 · Received January 10, 2011

    Report

    Report Number
    1717344-2011-00013
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 29, 2010
    Report Date
    December 17, 2010
    Manufacturer
    COVIDIEN LP, (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE OPERATED AUTOMATICALLY, EVEN THOUGH, THE ACTIVATION BUTTON WAS NOT PUSHED. 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) 189303

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK