BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 2083463 · Received May 10, 2011

    Report

    Report Number
    3005075853-2011-01905
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    February 17, 2010
    Report Date
    February 19, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT CLOSED, FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITH OUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED WITHOUT ANY DIFFICULTIES NOTED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2010 THAT DURING A HAND ASSISTED LAPAROSCOPIC SURGERY, THE DEVICE WOULD NOT CLOSE ON THE FIRST FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011: THE SURGEON ADVISED HER THE PATIENT HAS CONTACTED HIM FOR INFORMATION REGARDING OUR DEVICE. THE SURGEON STATED THAT IN THE CASE ON (B)(6) 2010, THE COMPLAINT WAS "DEVICE MISFIRED WITH BLEEDING." THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE. (THIS INFORMATION WAS NOT REPORTED BY THE FACILITY AT THE TIME OF THE COMPLAINT.) THE PATIENT HAS REPORTED TO THE SURGEON THAT SINCE THE FIRST PROCEDURE THEY HAVE UNDERWENT A HERNIA REPAIR PROCEDURE AND AN LAPAROSCOPIC APPENDECTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4R70E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention