BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGASURE IMPACT LF4318

    MDR report key: 4227786 · Received November 5, 2014

    Report

    Report Number
    1717344-2014-00932
    Event Type
    Death
    Date Received
    November 5, 2014
    Report Date
    October 9, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE HAS BEEN DISCARDED. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT BLED OUT AND DIED AFTER UNDERGOING A PANCREATECTOMY. REPORTEDLY, HEMOSTASIS HAD BEEN ACHIEVED IN THE OPERATING ROOM, AND THE BLEEDING OCCURRED POST-OP. TO DATE, THE SITE HAS NOT PROVIDED ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710599 LIGASURE IMPACT LF4318 LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP LF4318

    Patients

    Seq Age Sex Outcome Treatment
    1 Death