BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS LINEAR CUTTER

    MDR report key: 3870857 · Received June 12, 2014

    Report

    Report Number
    3005075853-2014-03961
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    April 30, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DAMAGED YOKE TEETH. THE ANALYSIS RESULTS FOUND THAT AN ATS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH NO RELOAD LOADED IN THE DEVICE. THE CLAMPING MECHANISM WAS NOTED TO BE DAMAGED. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE YOKE TEETH WERE FOUND BROKEN. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE YOKE TEETH BECAME BROKEN, THIS DAMAGE CAN OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE CLOSING TRIGGER WHEN THE JAWS ARE CLAMPED ON TISSUE THICKER THAN INDICATED. IN ADDITION, IT SHOULD BE NOTED THAT AT LEAST A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    Description of Event or Problem · 1

    THE DEVICES RECEIVED WITH NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347136 ETS LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1