BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2081657 · Received May 9, 2011

    Report

    Report Number
    3005075853-2011-01854
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 12, 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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EC60A DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH AN ECR60W CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED 1/10; IN ADDITION, 5 B-FORMED STAPLES WERE RECEIVED IN THE CHANNEL BAG. 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. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A DEVICE WITH THE INDICATOR IN THE LOCKED POSITION A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. THE RETURNED DEVICE AND CARTRIDGE RELOAD WERE TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION BY RESETTING AND RELOADING IT INTO THE DEVICE. THE DEVICE ACHIEVED ITS COMPLETE 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. 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 GASTRIC BYPASS PROCEDURE, THE DEVICE WOULD NOT OPEN, AFTER USING THREE WHITE RELOADS WITHOUT A PROBLEM THE SURGEON PLACED THE FOURTH RELOAD WITHOUT DIFFICULTY BUT THE JAWS WOULDN'T REOPEN. THIS DEVICE AND THE RELOAD ARE AVAILABLE FOR EXPERTISE. THE SURGEON USED A SECOND STAPLER AND WITH THE SECOND RELOAD AND THE JAWS STAYED CLOSED ON THE TISSUES. THERE WERE SECTION AND STAPLING. THE SURGEON REOPENED THE JAWS USING THE RED BUTTON. NO DAMAGES ON THE TISSUES. NO UNEXPECTED NOISE HEARD AND NO UNEXPECTED RESISTANCE FELT. THE SURGEON PERFORMED THE PROCEDURE WITH THIS SAME DEVICE. NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H4347J

    Patients

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