BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD RELOAD FOR ECHELON

    MDR report key: 2991583 · Received March 6, 2013

    Report

    Report Number
    3005075853-2013-01108
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 20, 2013
    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
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PREMATURE SLED MOVEMENT. THE ANALYSIS RESULTS SHOWED THAT ONE RELOAD WAS RECEIVED PARTIALLY FIRED 1/16. 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 RETURNED RELOAD WAS RESET AND LOADED INTO A TEST DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION AND 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. NO MALFORMED STAPLES WERE NOTED DURING FIRING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    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 SLEEVE GASTRECTOMY PROCEDURE, THE RELOAD DID NOT FORM THE STAPLE. ANOTHER LIKE RELOAD 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
    94793 GOLD RELOAD FOR ECHELON STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CN12

    Patients

    Seq Age Sex Outcome Treatment
    1