BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON* 60 ENDOPATH** STAPLER

    MDR report key: 2420208 · Received January 18, 2012

    Report

    Report Number
    3005075853-2012-00302
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Date of Event
    December 16, 2011
    Report Date
    January 4, 2012
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). WRONG ORIENTATION IDLER GEAR. THE ANALYSIS RESULTS SHOWED THAT ONE DEVICE (A) WAS RETURNED IN GOOD VISUAL CONDITION AND WITH A RELOAD PRESENT. THE RELOAD WAS RECEIVED PARTIALLY FIRED. THE FIRING MECHANISM WAS NOTED TO BE DAMAGED AS THE KNIFE WAS NOTED TO BE IN THE HOME POSITION AND THE THREE STROKE INDICATOR WAS BETWEEN 2 AND 3; NO FUNCTIONAL TEST COULD BE PERFORMED WITH THE RETURNED DEVICE. HOWEVER, THE RETURNED RELOAD WAS TESTED FOR FUNCTIONALITY WITH A TEST DEVICE. 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 RETURNED DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS; THE RELEASE BUTTON AND SEVERAL IDLER GEAR TEETH WERE NOTED TO BE DAMAGED, IN ADDITION THE IDLER GEAR AND INDICATOR GEAR WERE NOTED TO BE DESYNCHRONIZED. 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. WHEN ATTEMPTING TO FIRE, SIGNIFICANT RESISTANCE WILL BE FELT AS THE RELEASE BUTTON IS BLOCKING THE PATH OF THE INDICATOR GEAR ROTATION RESULTING IN THE INDENTATION OF THE ANVIL RELEASE BUTTON. IF THE FIRING STROKE IS CONTINUED PAST THIS POINT, THE IDLER GEAR CAN GET DAMAGED AND GET OUT OF SYNCHRONIZATION AS THE INDICATOR GEAR DOES NOT MOVE DUE TO THE INTERACTION WITH THE RELEASE BUTTON. FURTHERMORE THE INDICATOR GEAR PUSHES INTO ON THE RELEASE BUTTON, RESULTING IN DAMAGE OR BREAKAGE OF THE RELEASE BUTTON POST CLEARING THE PATH OF THE INDICATOR GEAR AND BEING ABLE TO CONTINUE WITH THE FIRING STROKE. ONCE THE GEARS ARE NOT SYNCHRONIZED THE DEVICE WILL NOT OPEN AS THE POSITION OF THE INDICATOR GEAR HAS TO BE HOME IN ORDER FOR THE DEVICE TO OPEN. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE DEVICE (B) WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH A CARTRIDGE RELOAD LOADED ON THE DEVICE. THE RELOAD 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 RELOAD BY RESETTING AND RELOADING IT 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. BATCH # H5375V (MFG DATE 10/17/2011; EXP DATE 09/17/206. PREMATURE SLED MOVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A VALID LOT NUMBER FOR THIS DEVICE WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE DEVICES WOULD NOT OPEN. IT WAS IMPOSSIBLE TO OPEN THE STAPLER AFTER IT PASSED THE TROCAR. ANOTHER LIKE 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** STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H44M8A

    Patients

    Seq Age Sex Outcome Treatment
    1 TROCAR