BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 ARTICULATING

    MDR report key: 2140508 · Received June 27, 2011

    Report

    Report Number
    3005075853-2011-02595
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE EC45A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR60W CARTRIDGE RELOAD LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A DEVICE THAT HAS BEING PARTIALLY FIRED OR FULLY FIRED A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER TO HANDLE IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. EVENT COULD NOT BE CONFIRMED AS THE DEVICE WAS RECEIVED WITH THE ANVIL OPENED AND THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING A LOBECTOMY PROCEDURE, THE DEVICE WOULD NOT OPEN. THE DEVICE WORKED PROPERLY WITH THE FIRST CARTRIDGE (TYPE OF THE CARTRIDGE: UNKNOWN). THE SURGEON CLOSED IT AND TOOK IT OUT FROM THE PATIENT TO PUT A NEW CARTRIDGE, BUT THE DEVICE WOULD NOT OPEN AGAIN. NO MORE INFORMATION. THE SURGEON USED ANOTHER LIKE DEVICE TO PERFORM THE PROCEDURE, WHICH ENDED WITHOUT FURTHER ISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43G0V

    Patients

    Seq Age Sex Outcome Treatment
    1