BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTO SUTURE-US SURGICAL

    MDR report key: 463800 · Received June 5, 2003

    Report

    Report Number
    463800
    Event Type
    Death
    Date Received
    June 5, 2003
    Date of Event
    March 5, 2003
    Report Date
    April 1, 2003
    Manufacturer
    *
    Product Code
    GAO
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE COMPLETION OF UPPER LOBE LOBECTOMY, WHEN THE DEVICE WAS PLACED ON THE TISSUE, QUESTION OF MISALIGNMENT OF THE DEVICE, THE DEVICE MISFIRED AND TORE (MADE A TEAR) ALONG THE PREVIOUS SUTURE LINE. UNABLE TO CONTROL THE BLEEDING, THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE-US SURGICAL TA-55 GAO * TA-55 4.8 P2D836 OR P1F229

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death