BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2090298 · Received May 16, 2011

    Report

    Report Number
    3005075853-2011-02001
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 11, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ONE PIECE SLED. THE EC60 INSTRUMENT WAS RECEIVED WITH NO VISUAL NON-CONFORMANCES. THE DEVICE WAS LOADED WITH AN UNFIRED RELOAD. 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. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON WENT TO FIRE THE DEVICE ACROSS THE BOWEL AND IT WOULDN'T FIRE. THE SURGEON REPOSITIONED IT BUT IT STILL WOULDN'T FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1