BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 2142617 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02656
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 7, 2011
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). YOKE FLANGE. THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND A RELOAD PRESENT. THE RELOAD WAS RECEIVED PARTIALLY FIRED AND WITH CARTRIDGE LOCKOUT SPRING DAMAGED. THE DAMAGE TO THE RELOAD LOCKOUT SPRING IS CONSISTENT WITH DAMAGE OBSERVED WHEN ATTEMPTING TO FIRE AN ALREADY SPENT CARTRIDGE. THE RELOAD IS DESIGN TO LOCK OUT AFTER A PARTIAL OR COMPLETE FIRE TO AVOID RE FIRING A PARTIALLY OR FULLY SPENT RELOAD. FIRING THROUGH THE LOCKOUT MECHANISM CAN BREAK THE DEVICE. FOR MORE INFORMATION PLEASE REFER TO THE INSTRUCTIONS FOR USE. 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; THE FIRING TRIGGER TEETH AND THE YOKE FLANGE WERE FOUND BROKEN. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE YOKE BECAME DAMAGED, THIS DAMAGE CAN OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE CLOSING TRIGGER IN THE OPEN DIRECTION TO OVERCOME EXTRA FRICTION IN THE JAWS AS A RESULT OF THE JAWS BEING 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; (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NEPHRECTOMY PROCEDURE, THE DEVICE WAS PLACED ON THE TISSUE AND WOULD NOT FIRE THEN WOULD NOT OPEN. A COMPETITOR'S DEVICE WAS USED TO CUT OFF THE DEVICE FROM TISSUE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1