BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGASURE SMALL JAW

    MDR report key: 3082514 · Received April 19, 2013

    Report

    Report Number
    1717344-2013-00289
    Event Type
    Death
    Date Received
    April 19, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 18, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE HAS BEEN DISCARDED. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. 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 DEVICE WAS INITIALLY USED FOR A WHIPPLE PROCEDURE. THE CASE WAS WITHOUT ISSUE AND THE SURGEON STATED THERE WERE NOT ANY PROBLEMS WITH THE DEVICE. ON (B)(6), THE PT SHOWED SIGNS OF INTERNAL BLEEDING. THE PT WAS RETURNED TO SURGERY AND WAS FOUND TO HAVE BLEEDING FROM THE MESENTERY. A SECOND SURGERY WAS PERFORMED AND THE PT PASSED AWAY THAT DAY. ADD'L QUESTIONS CONCERNING THE INCIDENT HAVE BEEN ASKED OF THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170295 LIGASURE SMALL JAW LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death