BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2220395 · Received August 23, 2011

    Report

    Report Number
    3005075853-2011-03458
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    June 13, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JAMMED KNIFE. THE ANALYSIS FOUND THAT THE EC60 DEVICE WAS RECEIVED WITH THE KNIFE JAMMED AND WITHOUT A RELOAD PRESENT. AFTER FURTHER INSPECTION OF THE DEVICE, DRY BODY FLUIDS AND A B-FORMED STAPLE WERE FOUND BEHIND THE KNIFE, RESULTING IN THE FIRING MECHANISMS JAMMING. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. THE DEVICE WAS CLEANED AND TESTED FOR FUNCTIONALITY WITH A TEST RELOAD. THE DEVICE 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. THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT UPPER LOBE WEDGE RESECTION PROCEDURE, THE DEVICE WOULD NOT RELEASE CORRECTLY. THE DEVICE WAS JAMMING. THEY HAD TO USE FOUR RELOADS DUE TO THE JAMMING. THE DEVICE WAS SWISHED IN WATER SOLUTION BETWEEN RELOADS. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43F66

    Patients

    Seq Age Sex Outcome Treatment
    1