BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 3131364 · Received May 20, 2013

    Report

    Report Number
    1717344-2013-00369
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    January 1, 2012
    Report Date
    April 26, 2013
    Manufacturer
    COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SEALED ARE OF THE PATIENT'S ADRENAL GLAND BEGAN TO BLEED DURING A LIVER RESECTION. THE PATIENT REQUIRED A BLOOD TRANSFUSION BUT IT IS UNK HOW MANY UNITS WERE NEEDED. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223301 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention