BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 1904168 · Received November 15, 2010

    Report

    Report Number
    1717344-2010-00836
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED, BUT TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D 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 DURING A DONOR NEPHRECTOMY CASE, THE DEVICE WAS ACTIVATING WITHOUT PRESSING THE ACTIVATION BUTTON. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITHOUT INCIDENT. 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) 183095

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK