BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH

    MDR report key: 2120989 · Received June 13, 2011

    Report

    Report Number
    3005075853-2011-02370
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT ONE EC60 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE 3-STROKE 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    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 STAPLES WERE MALFORMED AT THE SECOND FIRING SECOND STROKE. ANOTHER 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 60 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1