BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX

    MDR report key: 1902383 · Received November 18, 2010

    Report

    Report Number
    3005075853-2010-06581
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE-INTERRUPTED CYCLE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD IN THE DEVICE. THE RETURNED RELOAD WAS PARTIALLY FIRED WHICH INDICATES THAT THE DEVICE'S FIRING CYCLE WAS INTERRUPTED. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT, AND ALL THE STAPLES FORMED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE CARTRIDGE WAS LOADED INTO THE DEVICE WITHOUT DIFFICULTIES AND DID NOT FALL OUT DURING THE VISUAL AND FUNCTIONAL TESTING. THE EVENT DESCRIPTION INDICATES THE POTENTIAL FOR AN IMPROPERLY INSTALLED CARTRIDGE; EITHER THE CARTRIDGE IS NOT FULLY INSERTED INTO THE CHANNEL OR IT IS "LONG LOADED". IF "LONG LOADED" THE CARTRIDGE EXTENDS BEYOND THE CARTRIDGE JAWS FURTHER THAN IT SHOULD (HOLDING FEATURES OF THE CARTRIDGE ARE NOT SNAPPED INTO THE CHANNEL SLOTS AND THE HOLDING FEATURES ARE IN FRONT OF THE CHANNEL). IF THE CARTRIDGE IS NOT PROPERLY SNAPPED INTO THE CHANNEL OR IS "LONG LOADED" THE CARTRIDGE CAN MOVE FORWARD DURING THE FIRING STROKE AND SOME STAPLES MAY BE DEPLOYED, THE DEVICE WILL CONTINUE TO CUT, AND THE CARTRIDGE MAY BE PUSHED OUT. 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 A COLECTOMY WITH APPENDECTOMY PROCEDURE, WHEN THEY WERE FIRING ACROSS THE APPENDIX THE CARTRIDGE FELL OUT WHEN THEY CLOSED THE TRIGGER. THE DEVICE HAD MALFORMED STAPLES AND HAD PARTIALLY FIRED. THEY USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1