BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 1953896 · Received December 15, 2010

    Report

    Report Number
    1717344-2010-00950
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE HAS BEEN DISCARDED. IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE DEVICE JAW WAS LOCKED, THE DEVICE ACTIVATED EVEN WITHOUT PUSHING THE ACTIVATION BUTTON OR FOOTPEDAL. THERE WAS NO PT INJURY. THIS OCCURRED WITH ANOTHER DEVICE WITHIN THE SAME SURGERY. THIS DEVICE CAN BE FOUND ON MFR REPORT# 1717344-2010-00949.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK