BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2150412 · Received July 6, 2011

    Report

    Report Number
    3005075853-2011-02760
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 14, 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
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ONE EC60 DEVICE WAS RETURNED WITH A RELOAD PRESENT. THE RELOAD WAS RECEIVED PARTIALLY FIRED AND WITH THE PAN DAMAGED FROM THE PROXIMAL END. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD; THE DEVICE ACHIEVED COMPLETE 3-STROKES AND FIRED WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE ACHIEVED A COMPLETE FIRING CYCLE, THE STAPLES FORMED AS INTENDED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH NO CONCLUSION COULD BE REACHED ON WHAT MAY HAVE CAUSED THE DAMAGE TO THE PAN, IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WEDGE RESECTION (LUNG) PROCEDURE, THE FIRST FIRE DIDN'T PERFORM WELL (ONLY A SMALL CUT AND STAPLE LINE - AROUND 20 MM ONLY) AND THE SECOND FIRE DIDN'T PERFORM STAPLE AT ALL (INSTRUMENT ONLY CUT - NO STAPLE LINE AT ALL). THERE WAS AN AIR LEAK FROM THE LUNG AND THE SURGEON TOOK CONTROL OF THE LEAK WITH PDF/VICRIL. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR60D