BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTO SUTURE TACKER

    MDR report key: 490859 · Received October 23, 2003

    Report

    Report Number
    490859
    Event Type
    Death
    Date Received
    October 23, 2003
    Date of Event
    June 1, 2002
    Report Date
    July 1, 2003
    Manufacturer
    UNITED STATES SURGICAL, TYCO HEALTHCARE GROUP, LP
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD MULTIPLE VENTRAL HERNIA REPAIRS, THE LAST WAS IN 2003. READMITTED TO ANOTHER HOSPITAL ONE MONTH LATER, HYPOTENSIVE WITH FREE AIR IN THE ABDOMEN. EXPLORATORY LAPAROTOMY WITH MESH REMOVAL DONE, SMALL BOWEL RESECTION PERFORMED. MULTIPLE COMPLICATIONS AND DEATH FOLLOWED. DURING THE EXPLORATORY LAPAROTOMY THE SURGEON THOUGHT THE TITANIUM TACK HOLDING THE MESH MAY HAVE ERODED INTO THE SMALL BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE TACKER SINGLE USE DELIVERY DEVICE WITH 20 HELICAT FASTENERS KOG UNITED STATES SURGICAL, TYCO HEALTHCARE GROUP, LP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death