BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 8646100 · Received May 28, 2019

    Report

    Report Number
    3005075853-2019-19350
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    April 11, 2019
    Report Date
    May 3, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001072
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SEE USER FACILITY MEDWATCH # (B)(4). INVESTIGATION SUMMARY: THE ANALYSIS SHOWED THAT AN ATS45 DEVICE WAS RECEIVED WITH NO CARTRIDGE RELOAD PRESENT. ADDITIONALLY, THE DEVICE WAS NOTED TO HAVE INSUFFICIENT ANVIL CRIMP. NO FUNCTIONAL WAS PERFORMED DUE THE CONDITION OF THE DEVICE. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: CAN YOU PLEASE PROVIDE MORE EVENT DETAILS? DURING LAPAROSCOPIC APPENDECTOMY PROCEDURE THE SCRUB TECH AND SURGEON DID NOT FEEL COMFORTABLE WITH THE SECURITY OF THE DEVICE ANVIL. I WAS CONTACT AND VIEWED WHAT APPEARED TO BE A LOOSE JAW AND FILED THIS PC. THE DEVICE WAS NEVER FIRED, AND A NEW/ LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. DID THE DEVICE LOCK-OUT (NO STAPLES DEPLOYED, AND NO CUT LINE STARTED)? NO. OR, DID THE DEVICE PARTIALLY FIRE (START TO DEPLOY STAPLES AND CUT BUT COULD NOT BE COMPLETED)? NO. DID THE DEVICE DELIVER ANY STAPLES? NO. IF YES, WERE THE STAPLES THAT DEPLOYED INTO THE TISSUE IN THE PROPER CLOSED B-FORMATION? WAS THERE ANY DIFFICULTY INSTALLING THE CARTRIDGE INTO THE JAWS OF THE STAPLER? OR, WAS THERE AN ISSUE WITH THE ARTICULATION OF THE DEVICE? OR, WAS THERE DIFFICULTY CLOSING THE JAW OF THE DEVICE? IF YES, PLEASE EXPLAIN. STAPLES WERE NEVER LOADED INTO THE DEVICE - [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AND UNKNOWN PROCEDURE, PRIOR TO LOADING THE DEVICE WITH A RELOAD, THE CIRCULATOR NOTICED THAT ANVIL JAW WAS LOSE. I INSPECTED THE DEVICE AND THIS APPEARS TO BE THE CASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITHOUT ANY PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437909 ETS FLEX ARTICNG LNR CUTR 45MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. T9235K 10705036001072

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR