BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 1832298 · Received September 13, 2010

    Report

    Report Number
    3005075853-2010-05219
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE RELOAD WAS INSTALLED WITHOUT ANY DIFFICULTIES AND DID NOT FELL OUT DURING FUNCTIONAL TESTING. 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 LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE WAS FIRED AND THE CARTRIDGE CAME HALFWAY OUT OF THE JAWS. THE DEVICE WAS RELOADED AND FIRED FINE. THERE WAS NO IMPACT TO THE PATIENT. (B)(4)

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1