BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS LINEAR CUTTER

    MDR report key: 4081429 · Received September 11, 2014

    Report

    Report Number
    3005075853-2014-06329
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    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 AND WITH THE LOCKOUT TAB DAMAGED. IT SHOULD BE NOTED THAT THE DEVICE IS DESIGNED WITH A LOCKOUT SYSTEM IN ORDER TO AVOID TO FIRE THE DEVICE WITH A SPEND CARTRIDGE. ADDITIONALLY, THE RETURNED CARTRIDGE WAS DISASSEMBLED IN ORDER TO VERIFY THE CONDITION OF INTERNAL COMPONENTS AND NO ANOMALIES WERE NOTED. 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. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. 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 A NEPHRECTOMY PROCEDURE; ON THE SECOND FIRING WITH A BLUE RELOAD, THE STAPLER JAMMED AFTER THE KNIFE BLADE WAS DEPLOYED. THE SURGEON NOTED THE STAPLER WOULD NOT OPEN OFF OF THE RENAL ARTERY AFTER MULTIPLE ATTEMPTS. THE STAPLER WAS SLID OFF THE VESSEL AND IT WAS NOTED THAT ONLY A FEW STAPLES FORMED ON THE SPECIMEN SIDE-THE VENA CAVA WAS CUT, WITH NO STAPLES FORMED, RESULTING IN APPLICATION OF SUTURES AND CLIPS TO ACHIEVE HEMOSTASIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562551 ETS LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4ER45

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - 6R45B