BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON, ENDOPATH

    MDR report key: 1221283 · Received October 23, 2008

    Report

    Report Number
    1221283
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 2, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE STAPLER FAILED TO CLOSE COMPLETELY AT THE DISTAL END. THE SURGEON DECIDED NOT TO FIRE THE STAPLER CONSIDERING ITS FAILURE TO CLOSE. STAPLER WAS REMOVED FROM THE FIELD. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON, ENDOPATH STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. * C4E09M

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR