BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 45 ENDOPATH STAPLER

    MDR report key: 2181659 · Received July 27, 2011

    Report

    Report Number
    3005075853-2011-03021
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 4, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EC45 DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH A CARTRIDGE RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED (B)(4). 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT LOBECTOMY PROCEDURE, THE DEVICE WOULD NOT OPEN. THE DEVICE CLOSED PROPERLY, BUT WOULD NOT OPEN. THIS HAPPENED WITH THE FIRST BLUE RELOAD. THE INCIDENT OCCURRED AT THE FIRST FIRING. NO BUTTRESSING MATERIAL WAS USED. THE INSTRUMENT WAS NOT FIRED NEXT TO AN EXISTING STAPLE LINE. NO UNEXPECTED NOISE WAS HEARD. AFTER USE, BUTTONS AND TRIGGERS DID NOT RETURN TO THEIR ORIGINAL POSITION BECAUSE THE DEVICE WAS BLOCKED IN A CLOSED POSITION. THE SURGEON HAD SOME DIFFICULTIES REMOVING THE DEVICE FROM THE TISSUE BECAUSE IT WAS CLOSED ON THE PATIENT'S LUNG, SO THE SURGEON HAD TO CUT AROUND TO TAKE IT OFF. THE SURGEON USED ANOTHER LIKE DEVICE TO PERFORM THE PROCEDURE, WHICH ENDED WITHOUT FURTHER ISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 45 ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK E4L822

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-(B)(4)