BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ETS FLEX 45 ARTICULATING ENDOSCOPIC LINEAR CUTTER

    MDR report key: 3944688 · Received July 11, 2014

    Report

    Report Number
    MW5037292
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC APPENDECTOMY. DURING PROCEDURE, STAPLER WAS LOADED. THE STAPLER MISFIRED AND THE STAPLE LINE OPENED. NO INJURY TO PT AND STAPLER WAS CHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406966 ENDOPATH ETS FLEX 45 ARTICULATING ENDOSCOPIC LINEAR CUTTER ENDOPATH ETS FLEX 45 GDW ETHICON ENDO SURGERY L4EH7C

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention