BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 ARTICULATING

    MDR report key: 2240658 · Received September 9, 2011

    Report

    Report Number
    3005075853-2011-03704
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 16, 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). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE EC45A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE. 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. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VISCERAL PROCEDURE, THE DEVICE WOULD NOT OPEN. THE DEVICE WORKED PROPERLY DURING THE PRE-TESTS, AND THEN WHEN THE SURGEON WANTED TO USE IT ON THE PATIENT, IT WAS IMPOSSIBLE TO OPEN. THE SURGEON REMOVED THE DEVICE FROM THE PATIENT, OPENED IT WITH THE SECURITY SYSTEM AND THE SECOND PRE-TEST WAS OK. THE SURGEON TRIED USING THE DEVICE A SECOND TIME ON THE PATIENT BUT THIS TIME THE DEVICE DID NOT STAPLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43K8P

    Patients

    Seq Age Sex Outcome Treatment
    1