BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGASURE XTD DISP ELEC/CORD

    MDR report key: 491027 · Received October 21, 2003

    Report

    Report Number
    1717344-2003-00121
    Event Type
    Death
    Date Received
    October 21, 2003
    Date of Event
    September 10, 2003
    Report Date
    October 1, 2003
    Manufacturer
    VALLEYLAB-USS
    Product Code
    JOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE PT WAS BEING TREATED FOR DIGESTIVE HEMORRHAGES AND IN VERY CRITICAL CONDITION PRIOR TO THE FIRST SURGERY. THE ACTUAL PROCEDURE BEING PERFORMED IS UNCLEAR AT THIS TIME. THE PANCREATIC DUODENAL VEIN WAS SEALED WITH THE LIGASURE DEVICE. A RE-OPERATION HAD TO BE PERFORMED BECAUSE IT WAS FELT THE PT WAS BLEEDING INTERNALLY AND THEIR CONDITION WAS DETERIORATING. THE SURGEON DISCOVERED THE ORIGINAL LIGASURE SEAL WAS NOT "GOOD". THE PT DIED 15-20 HOURS AFTER THE SECOND OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE XTD DISP ELEC/CORD SURGICAL VESSEL/TISSUE SEALER JOS VALLEYLAB-USS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death UNK ELECTROSURGICAL GENERATOR