BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2891022 · Received November 15, 2012

    Report

    Report Number
    1717344-2012-01172
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR 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 DURING AN OPEN GASTRECTOMY, BLEEDING WAS NOTED FROM THE SEALED AREA, ALTHOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE WAS PROVIDED BY THE GENERATOR. THE AMOUNT OF BLOOD LOSS WAS DESCRIBED AS BEING ONE DROP OF BLOOD AND WAS VERY MINOR. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2GF019X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK