BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS LINEAR CUTTER

    MDR report key: 3830498 · Received May 23, 2014

    Report

    Report Number
    3005075853-2014-03537
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH FOUR 6R45B CARTRIDGES PRESENT. THE RELOADS WERE RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, 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. EVENT COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED DURING THE FUNCTIONAL TESTING. 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 AN UNKNOWN BARIATRIC PROCEDURE, DURING THE 4TH FIRING OF THE DEVICE, IT STAPLED BUT ONLY CUT HALFWAY ALONG THE STAPLE LINE. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308545 ETS LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - 6R45B X 4