BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 45 ENDOPATH

    MDR report key: 2021643 · Received March 17, 2011

    Report

    Report Number
    3005075853-2011-01052
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 17, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IDLER GEAR TEETH; LINK TEETH. THE ANALYSIS RESULTS FOUND THAT ONE EC45 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND A RELOAD LOADED. THE RELOAD WAS RECEIVED PARTIALLY FIRED. THE DEVICE WAS RETURNED WITH THE ANVIL AND CLOSING TRIGGER IN THE CLOSE POSITION. ADDITIONALLY THE KNIFE WAS NOTED TO BE IN THE HOME POSITION AND THE 3 STROKE INDICATOR IN THE I POSITION. THE MANUAL RELEASE WAS PULLED SEVERAL TIMES AND THE 3-STORE INDICATOR WAS SPINNING FREELY. THE INDICATOR WAS SET TO THE HOME POSITION AND THE DEVICE WAS ABLE TO OPEN. THE RETURNED RELOAD WAS TESTED FOR FUNCTIONALITY BY RESETTING AND RELOADING IT INTO THE DEVICE. THE FUNCTIONAL TEST DEMONSTRATED THAT THE REMAINING STAPLES IN THE RELOAD FORMED PROPERLY AND THE INSTRUMENT ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITIONS OF THE INTERNAL COMPONENTS AND THERE WAS DAMAGE NOTED ON THE INDICATOR GEAR AND DRIVER LINKS. IN ADDITION DAMAGE WAS NOTED ON THE LEFT SHROUD FROM THE MANUAL RELEASE LEVER. IT IS POSSIBLE THAT THE MANUAL RELEASE LEVER WAS NOT FULLY SEATED AND RESULTED IN THE MISALIGNMENT OF THE GEARS AND DRIVER LINKS. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHILE FIRING THE FIRST RELOAD THE INSTRUMENT BLOCKED AND FAILED TO FIRE, FAILED TO OPEN. EVEN AFTER PULLING THE MANUAL RELEASE IT DIDN`T OPEN, IT BLOCKED TOTALLY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 45 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4RF9L

    Patients

    Seq Age Sex Outcome Treatment
    1