BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 45 ENDOPATH

    MDR report key: 2133601 · Received June 20, 2011

    Report

    Report Number
    3005075853-2011-02486
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE PIECE SLED. THE EC45 INSTRUMENT WAS RECEIVED WITH NO VISUAL NON-CONFORMANCES. THE DEVICE WAS LOADED WITH AN UNFIRED RELOAD PRESENT. UPON FURTHER INSPECTION OF THE RELOAD, THE ONE-PIECE SLED WAS FOUND DAMAGED. IMPROPER LOADING OF THE RELOAD MAY DAMAGE THE SLED. IF THE RELOAD IS NOT FULLY SEATED WHEN THE DEVICE IS CLOSED, THE SLED WILL BREAK. WHEN INSERTING THE RELOAD, SLIDE IT AGAINST THE BOTTOM OF THE RELOAD JAW UNTIL THE RELOAD ALIGNMENT TAB STOPS IN THE RELOAD ALIGNMENT SLOT. SNAP THE RELOAD SECURELY IN PLACE. THE INSTRUMENT IS NOW LOADED AND READY FOR USE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR THE COMPLETE GUIDE TO LOADING AND RELOADING THE INSTRUMENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE DEVICE JAMMED AND WOULD NOT FIRE. NO OTHER INFORMATION WAS AVAILABLE DUE TO THE DEVICE WAS LEFT IN PURCHASING WITH A NOTE AND NO ADDITIONAL CONTACT. THEY COMPLETED THE PROCEDURE WITH A NEW LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 45 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G41075R

    Patients

    Seq Age Sex Outcome Treatment
    1