BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2150826 · Received July 6, 2011

    Report

    Report Number
    3005075853-2011-02785
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 20, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JAMMED KNIFE, RELEASE BUTTON POST. THE EC60 DEVICE WAS RETURNED WITH THE ANVIL CLOSED. A RELOAD WAS RECEIVED LOADED ON THE DEVICE AND VOID OF STAPLES. UPON FURTHER INSPECTION OF THE DEVICE, A PIECE OF CLIP WAS FOUND LODGED IN THE CARTRIDGE KNIFE SLOT PREVENTING THE KNIFE FROM RETURNING COMPLETELY AND THE ANVIL FROM OPENING. IN ADDITION, A PIECE OF CLIP WAS FOUND IN THE CARTRIDGE DECK. WHEN PLACING THE INSTRUMENT ON THE TISSUE TO BE STAPLED, ENSURE THAT NO HARD OBSTRUCTION (SUCH AS A CLIP) IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR WARNINGS AND PRECAUTION REGARDING FIRING ACROSS HARD OBJECTS. THE CLIP WAS REMOVED AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD; THE DEVICE ACHIEVED A COMPLETE 3-STROKES FIRE WITHOUT ANY DIFFICULTIES NOTED. HOWEVER, THE FIRING MECHANISM WAS NOT WORKING PROPERLY. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND THE RELEASE BUTTON POST WAS NOTED TO BE BROKEN, THIS IS CONSISTENT WITH PARTIALLY ENGAGING THE ANVIL RELEASE BUTTON INADVERTENTLY AFTER CLOSING THE DEVICE BUT BEFORE FIRING. THIS CAUSES THE RELEASE BUTTON TO PARTIALLY ENGAGE WITH THE INDICATOR GEAR. AS A RESULT OF THIS CONDITION, WHEN ATTEMPTING TO FIRE, SIGNIFICANT RESISTANCE WILL BE FELT DUE TO THE FACT THAT THE RELEASE BUTTON IS BLOCKING THE PATH OF THE INDICATOR GEAR. IF THE FIRING STROKE IS CONTINUED PAST THIS POINT, THE INDICATOR GEAR PUSHES INTO ON THE RELEASE BUTTON, RESULTING IN DAMAGE OR BREAKAGE OF THE RELEASE BUTTON. THE DEVICE OPENED AND CLOSED WITHOUT DIFFICULTIES. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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 INSTRUMENT DID NOT OPEN AFTER THE FIRST FIRING. HOW THE INSTRUMENT WAS OPENED AND TAKEN OF THE TISSUE IS UNKNOWN. THE PROCEDURE WAS FINISHED WITH ANOTHER EC60 WITHOUT PROBLEMS. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE EVENT OCCURRED DURING LAP GASTRIC BYPASS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H4323D

    Patients

    Seq Age Sex Outcome Treatment
    1