BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGASURE SYSTEM GENERATOR-DOM

    MDR report key: 968852 · Received December 21, 2007

    Report

    Report Number
    1219930-2007-00858
    Event Type
    Death
    Date Received
    December 21, 2007
    Date of Event
    July 1, 2007
    Report Date
    December 7, 2007
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE INCIDENT GENERATOR HAS NOT BEEN RECEIVED FOR EVALUATION, BUT THE SITE HAS REPORTED THEY ARE SENDING IT BACK FOR EVALUATION AS NOW THEY HAVE HAD THREE ADVERSE EVENTS FOLLOWING SURGERIES IN WHICH THIS GENERATOR WAS USED. THE SITE REPORTED ALL THREE ADVERSE EVENTS TO COVIDIEN LP (FORMERLY VALLEYLAB). THE OTHER TWO ADVERSE EVENTS ARE REPORTED ON MFR REPORTS #1219930-2007-00855 AND 1219930-2007-00857. THE ACCESSORY HANDPIECES HAVE ALL BEEN DISCARDED. THE SITE HAS BEEN ASKED TO PROVIDE THE NAME OF THE LARGER FACILITY THE PATIENT WAS TRANSFERRED TO SO THAT ADDITIONAL INFORMATION MAY BE OBTAINED. THE REPORTING SITE WAS ALSO REQUESTED TO PROVIDE THE AGE OF THE PATIENT, MEDICAL HISTORY AND A COPY OF THE AUTOPSY REPORT. THIS INFORMATION HAS NOT YET BEEN PROVIDED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING RECOVERY AFTER AN OPEN BOWEL RESECTION, THE PATIENT'S BLOOD PRESSURE SUDDENLY DROPPED FROM NORMAL TO ZERO. THIS WAS A COUPLE OF HOURS AFTER THE SURGERY. THE PATIENT WAS RESUSCITATED AND TRANSFERRED TO A LARGER FACILITY THAT WOULD HAVE ENOUGH BLOOD TO HANDLE THE REQUIRED TRANSFUSION AND REOPERATION, AS THE OPERATING SITE WAS A SMALL RURAL HOSPITAL. THE PATIENT EXPIRED AT THIS SECOND HOSPITAL SO THE REPORTING SITE DOES NOT HAVE A RECORD OF THE DATE THE PATIENT EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Death LS1120