BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60

    MDR report key: 2003893 · Received March 1, 2011

    Report

    Report Number
    3005075853-2011-00776
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    October 20, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ONE (B)(4) DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH A FULLY FIRED RELOAD LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT ACHIEVED A COMPLETE 3-STROKES FIRE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED AND NO ABNORMITIES WERE NOTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE DID NOT FIRE ACCORDING TO THE REPORT RECEIVED. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL FOLLOWUP: THE LOAD DID NOT WORK. THERE WAS NOT ANY STAPLING. THE SALES REPRESENTATIVE SAID THAT ACCORDING TO THE DOCTOR, BOTH STAPLERS DID NOT CUT OR STAPLE DUE TO THE THICKNESS OF THE PATIENT'S TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4T716

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention