BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATW 35-ENDOPATH ETS

    MDR report key: 2192611 · Received August 2, 2011

    Report

    Report Number
    MW5021588
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE STAPLER WAS PLACED INTRA-OP (LAPAROSCOPY) TO STAPLE THE RIGHT FALLOPIAN TUBE BUT FAILED TO ENGAGE AND STAPLE. THE STAPLER WAS REMOVED INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATW 35-ENDOPATH ETS ARTICULATING LINEAR CUTTER VASCULAR GDW ETHICON, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention