BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE

    MDR report key: 1053119 · Received May 20, 2008

    Report

    Report Number
    1053119
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS STAPLING A PORTION OF THE COLON WHEN THE GUN MISFIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CUTTER GCJ ETHICON ENDO-SURGERY, INC. TLC75 E4KU13

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR