BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 1812768 · Received August 18, 2010

    Report

    Report Number
    3005075853-2010-04695
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 4, 2010
    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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE (B)(4) DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH TWO CARTRIDGE RELOADS PRESENT. RELOAD (C) WAS UNFIRED. RELOAD (B) WAS RECEIVED PARTIALLY FIRED 1/10. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED CARTRIDGE RELOADS WERE TESTED FOR FUNCTIONALITY BY RESETTING AND RELOADING RELOAD (B) INTO THE DEVICE. THE FUNCTIONAL TEST DEMONSTRATED THAT THE REMAINING STAPLES IN THE CARTRIDGE RELOAD FORMED PROPERLY AND THE INSTRUMENT ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. 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 TO BAXTER (B)(4) THAT AT LEAST TWENTY INTERMATE DEVICES WERE LEAKING FROM THE WINGED LUER CAP BEFORE USE. THIS IS REPORT NUMBER 20 OF 20. THE DEVICES WERE FILLED WITH PAMIDRONATE WHEN THE LEAKS WERE OBSERVED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE FIRST RELOAD CAN'T FIRE PROPERLY AND GOT STUCK. THE NURSE CHANGED A NEW DEVICE TO FINISH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA C4RU5E

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G, LOT# G4RP6J