BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 1811575 · Received August 23, 2010

    Report

    Report Number
    3005075853-2010-04787
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 15, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PAN DISLODGED. THE ANALYSIS RESULTS FOUND THAT ONE (B)(4) DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH A RELOAD PAN FOUND LODGE INSIDE THE CHANNEL PREVENTING ADDITIONAL CARTRIDGE RELOADING. THE PAN WAS REMOVED FROM THE CHANNEL AND THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT AND ARTICULATED POSITIONS WITH A TEST RELOAD. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. THE DEVICE OPENED AND CLOSED WITHOUT DIFFICULTIES. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE PAN BECAME DISLODGED FROM THE RELOAD, IN ADDITION IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THORACOTOMY PROCEDURE THE DEVICE FIRED FINE ON THE FIRST FIRING. THEY TRIED TO RELOAD THE DEVICE WITH A SECOND GREEN LOAD AND THE DEVICE WOULD NOT LOAD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4R60G

    Patients

    Seq Age Sex Outcome Treatment
    1