BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS LINEAR CUTTER STAPLER

    MDR report key: 3824324 · Received May 21, 2014

    Report

    Report Number
    3005075853-2014-03392
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 10, 2014
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE EXPLAIN WHAT IS MEANT BY, ¿THE DEVICE WOULD NOT FIRE PROPERLY?¿ THE DEVICE FIRED, BUT STAPLES WENT EVERYWHERE AND DIDN'T CINCH TISSUE. BLUE LOADS 45 . TISSUE KEPT BLEEDING. I TRIED AGAIN WITH ANOTHER LOAD, BUT SAME THING. GT A NEW STAPLER WHICH FIXED THE PROBLEM. THE ANALYSIS RESULTS FOUND THAT THE ATS45 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 FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED 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. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED, A DEFECT WAS FOUND DURING THE MANUFACTURING OF THIS BATCH BUT WAS NOT RELATED TO THE EVENT DESCRIPTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY, THE FIRST TWO FIRINGS USING BLUE CARTRIDGES THE DEVICE WOULD NOT FIRE PROPERLY. A SECOND DEVICE WAS OPENED AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. THIS IS ALL THE INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301536 ETS LINEAR CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - TR45B