BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS LINEAR CUTTER

    MDR report key: 4180661 · Received October 17, 2014

    Report

    Report Number
    3005075853-2014-07181
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 29, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A TR45W CARTRIDGE LOADED IN THE DEVICE. THE RELOAD WAS 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 DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE ONLY THING REPORTED TO SALES REP WAS THIS, ¿WHEN DEVICE FIRED, THE BLADE DEPLOYED BUT THE STAPLES DID NOT." NO OTHER INFORMATION HAS BEEN GIVEN YET, BUT I ASKED ACCOUNT TO REACH OUT TO THE SURGEON TO GET MORE SPECIFIC DETAILS. I WAS TOLD BY THE SCRUB TECH DURING AN IN-SERVICE THAT THEY OPENED UP A COMPETITOR'S STAPLER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHEN THE DEVICE FIRED THE BLADE DEPLOYED BUT THE STAPLES DID NOT. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH A COMPETITORS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662687 ETS LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EC0E

    Patients

    Seq Age Sex Outcome Treatment
    1