BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1121583 · Received August 8, 2008

    Report

    Report Number
    1121583
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    April 28, 2008
    Report Date
    August 8, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STAPLING DEVICE MISFIRED. STAPLES DID NOT CLOSE PROPERLY. SURGEON USED ANOTHER STAPLING DEVICE SIZE 45 OVER THE PREVIOUS STAPLE LINE. THE DEVICE WAS A ECHELON 60 STAPLE RELOAD AND STAPLING GUN ECHELON LONG ENDO LINEAR CUTTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. * E4KC9C
    2 ETHICON ECHELON 60 STAPLE RELOAD STAPLER, SURGICAL, RELOAD GDW ETHICON ENDO-SURGERY, INC ECR60B D4JV62

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR