BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2091994 · Received May 18, 2011

    Report

    Report Number
    3005075853-2011-02025
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Report Date
    March 24, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE PIECE SLED INSTRUMENT B: BATCH # H50707, EXP DATE: 12/21/2015; MFR DATE: 01/21/2011: PREMATURE SLED MOVEMENT THE EC60 INSTRUMENT (A) 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. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. THE EC60 DEVICE (B) WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH A CARTRIDGE RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED 1/10. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED CARTRIDGE RELOAD BY RESETTING AND RELOADING IT INTO THE DEVICE. THE FUNCTIONAL TEST DEMONSTRATED THAT THE REMAINING STAPLES IN THE CARTRIDGE RELOAD FORMED PROPERLY AND THE INSTRUMENT ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC RECTAL PROCEDURE, THE INSTRUMENT COULD NOT BE CLOSED CORRECTLY BUT IT STAPLED AND CUT COMPLETELY. NO FURTHER INFORMATION IS AVAILABLE. 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 G4UG3Y

    Patients

    Seq Age Sex Outcome Treatment
    1