BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX 60 ENDOPATH STAPLER RELOAD

    MDR report key: 3921295 · Received July 8, 2014

    Report

    Report Number
    3921295
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 28, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ETHICON ENDOSURGERY, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN USING A DISPOSABLE STAPLER, THE STAPLE LOAD DID NOT WORK CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398303 ECHELON FLEX 60 ENDOPATH STAPLER RELOAD STAPLE, IMPLANTABLE, RELOAD GDW ETHICON ENDOSURGERY, LLC ECR60G *
    398304 ECHELON FLEX 60 ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDOSURGERY, LLC PLE60A *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR