BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGASURE IMPACT

    MDR report key: 1210987 · Received October 22, 2008

    Report

    Report Number
    1717344-2008-00484
    Event Type
    Death
    Date Received
    October 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    COVIDIEN LP, (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT : 10/22/2008. THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE HAS BEEN DISCARDED. IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT A PATIENT EXPIRED AFTER A PROCEDURE WHERE A LIGASURE VESSEL SEALING DEVICE AND A FORCETRIAD ELECTROSURGICAL GENERATOR WERE THOUGHT TO BE USED. THE GENERATOR, WHICH WAS PUT BACK INTO SERVICE AFTER THE INCIDENT, WAS CHECKED OUT BY THE HOSP BIOMEDICAL ENGINEER IN 2008 AND WAS FOUND TO HAVE NO PROBLEMS. AS THE PT DIED SEVERAL HRS AFTER SURGERY, THE SITE HAD NO REASON IMMEDIATELY AFTER THE PROCEDURE TO KEEP THE HANDPIECE AND IT WAS DISCARDED. MORE INFO WAS REQUESTED FROM THE SITE INCLUDING A NARRATIVE OF THE EVENT, DATE OF THE EVENT, MORE INFO AS TO THE PT AGE, GENDER AND CO-MORBIDITIES AND A COPY OF THE AUTOPSY RESULTS. THE SITE HAS INFORMED US THAT OUR QUESTIONS WILL NOT BE ADDRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP, (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death COVIDIEN FORCETRIAD ELECTROSURGICAL GENERATOR