BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 8860753 · Received August 5, 2019

    Report

    Report Number
    3005075853-2019-21014
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    January 1, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001072
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # R5AL0L. INVESTIGATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RECEIVED WITH THE FIRING TRIGGER BROKEN AND WITH NO CARTRIDGE LOADED ON THE DEVICE. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND NO ANOMALIES WERE NOTED. ALTHOUGH NO CONCLUSION COULD BE REACH ON WHAT CAUSED FIRING TRIGGER BROKE, IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED AND IDENTIFIED A [NR-0110630] RELATED TO THE REPORTED INCIDENT. THE NECESSARY ACTIONS TO ENSURE THE FINAL PRODUCT QUALITY HAVE BEEN TAKEN AND DOCUMENTED IN THE APPROPRIATE QUALITY SYSTEM. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY THAT FIRING TRIGGER BROKE OFF WHEN SURGEON WANTED TO FIRE. WHITE RELOAD WAS NOT FIRED. 2ND DEVICE DID NOT FIRE, COULD NOT BE CLOSED AND MOVED BACK THROUGH TROCAR. SOME STAPLES WERE IN ABDOMEN. STAPLER COULD BE CLOSED WITH MUCH FORCE. A LOT OF STAPLES WERE IN APPENDIX. APPENDIX HAD TO BE REMOVED LAPAROSCOPICALLY. PATIENT CONSEQUENCES WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656407 ETS FLEX ARTICNG LNR CUTR 45MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. T92E8L 10705036001072

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR