BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2112251 · Received May 27, 2011

    Report

    Report Number
    2112251
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    November 24, 2010
    Report Date
    April 21, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A SIDE-TO-SIDE ANASTOMOSIS WITH THE LINEAR CUTTER. THE LINEAR CUTTER MISFIRED WITH THE SECOND RELOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. NTLC75 G4TNIC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR