BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 1963840 · Received January 19, 2011

    Report

    Report Number
    3005075853-2011-00252
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 27, 2010
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE/INTERRUPTED FIRING. THE EC60 DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH A CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED. A PARTIAL FIRE CAN OCCUR IF THE FIRING SEQUENCE IS INTERRUPTED, THE DEVICE IS OPENED, THEN CLOSED AND FIRING IS RESUMED, CAUSING THE INSTRUMENT TO LOCKOUT. THE RETURNED CARTRIDGE RELOAD WAS TESTED FOR FUNCTIONALITY 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 WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND NO ANOMALIES WERE FOUND. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE COULD NOT BE OPENED AFTER FIRING. THE STAPLES WERE MALFORMED. THE SURGEON USED FORFEX TO THE REMOVE THE DEVICE FROM THE TISSUE. THE PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G, LOT #G4TV00