BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM

    MDR report key: 1242412 · Received November 24, 2008

    Report

    Report Number
    3005075853-2008-03322
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 7, 2008
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 11/24/2008. EVALUATION SUMMARY - THE ANALYSIS SHOWED THAT THE ATW35 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH NO RELOAD LOADED IN THE DEVICE. HOWEVER, THREE RELOADS WERE RECEIVED INSIDE THE BAG, RELOADS C AND D WERE RECEIVED FULLY FIRED, WITH THE LOCKOUT NORMAL. RELOAD B WAS RECEIVED PARTIALLY FIRED, WITH THE LOCKOUT NORMAL AND WITH DAMAGE ON THE PAN SURFACE. THE DAMAGE TO THE RELOAD PAN IS CONSISTENT WITH AN IMPROPER LOADING TECHNIQUE. IF THE CARTRIDGE IS NOT FULLY INSERTED INTO THE CHANNEL, WHEN THE DEVICE IS FIRED IT CAN CAUSE DAMAGE TO THE PAN. ADDITIONALLY, WHEN THE RELOAD IS LOADED IMPROPERLY OR LONG LOADING (HOLDING FEATURES OF THE CARTRIDGE ARE NOT SNAP ON THE CHANNEL WINDOWS) AT THE MOMENT OF THE FIRING, THE CARTRIDGE WILL BE EJECTED FORWARD AND SOME STAPES WILL BE DEPLOYED (APPROXIMATELY HALF WAY) AND MALFORMED BECAUSE OF INCORRECT ALIGNMENT. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT FIRED, CUT AND FORMED ALL THE STAPLES 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. THE DEVICE WAS BEING USED TO STAPLE THE APPENDIX. DURING CLOSURE AND COUNTING OFF OF PRODUCTS USED, IT WAS NOTICED THAT A RELOAD WAS MISSING. AN X-RAY WAS USED AND THE CARTRIDGE WAS FOUND IN THE ABDOMEN. THE PATIENT HAD TO BE REOPENED AND THE RELOAD WAS REMOVED. OVERSEWING WAS DONE TO THE STAPLE LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM GDW ETHICON ENDO-SURGERY, LLC NA E4LR5P

    Patients

    Seq Age Sex Outcome Treatment
    1