BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC

    MDR report key: 3842866 · Received June 2, 2014

    Report

    Report Number
    3005075853-2014-03642
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    April 11, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: DAMAGED FIRING TRIGGER TEETH, INCOMPLETE FIRING CYCLE, DAMAGED SPRING. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ANALYSIS RESULTS FOUND THAT THE ATW35 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH A TR35W CARTRIDGE LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED 1/4 AND WITH THE RELOAD LOCK OUT SPRING DAMAGED. THE DAMAGE TO THE RELOAD LOCKOUT SPRING IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. WHEN FIRING THE DEVICE MAKE SURE THAT THE FIRING STROKE IS COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. 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 THE FIRING TRIGGER TEETH WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACHED ON WHAT CAUSED THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO FIRE ON TICKER TISSUE THEN INDICATED OR ATTEMPTED TO FIRE TROUGH A LOCKED RELOAD IN PREVIOUS FIRINGS CAUSING AN INCREASE OF THE INTERNAL FORCES RESULTING IN THE COMPONENT YIELDING. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED WITH NO INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320881 ETS-FLEX - ENDOSCOPIC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DR30

    Patients

    Seq Age Sex Outcome Treatment
    1