BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 3621996 · Received January 31, 2014

    Report

    Report Number
    1717344-2014-00083
    Event Type
    Death
    Date Received
    January 31, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 24, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVE OR 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 DURING SURGERY, THE INSTRUMENT JAMMED. NO ILL EFFECT WAS NOTICED AT THAT TIME, BUT THE PATIENT DIED SOME DAYS AFTERWARDS. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68338 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 32320097X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death