BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSUTURE ENDOGIA UNIV 12MM

    MDR report key: 1003829 · Received February 11, 2008

    Report

    Report Number
    1003829
    Event Type
    Injury
    Date Received
    February 11, 2008
    Date of Event
    September 28, 2007
    Report Date
    December 13, 2007
    Manufacturer
    USSC/TYCO HEALTHCARE GROUP, LP
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STAPLER USED DURING A RIGHT HEPATIC LOBECTOMY. HOLE IN VENA CAVA MAY HAVE BEEN CAUSED BY THIS LOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE ENDOGIA UNIV 12MM STAPLER GAG USSC/TYCO HEALTHCARE GROUP, LP 030449 N7F23

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention