BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON* 60 ENDOPATH** STAPLER LONG ENDOSCOPIC LINEAR CUTTER - STRAIGHT 60 MM

    MDR report key: 2320584 · Received November 2, 2011

    Report

    Report Number
    3005075853-2011-04685
    Event Type
    Malfunction
    Date Received
    November 2, 2011
    Report Date
    August 31, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WRONG ORIENTATION IDLER GEAR, DAMAGED RELEASE BUTTON. ADDITIONAL DEVICE INFORMATION: DEVICE B: BATCH # H5227X, EXPIRATION DATE 06/08/2016. MANUFACTURER DATE 07/08/2011. TWO DEVICES (A-B) WERE RECEIVED FOR ANALYSIS. BOTH DEVICES WERE RETURNED WITH THE SHROUDS OPENED WITHOUT A RELOAD PRESENT. THE FIRING MECHANISMS WERE 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; THEREFORE, NO FUNCTIONAL TEST COULD BE PERFORMED. THE DEVICES WERE DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND 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. IF THE GEARS ARE NOT SYNCHRONIZED, THE DEVICE WILL NOT OPEN AS THE POSITION OF THE INDICATOR GEAR HAS TO BE IN THE HOME POSITION FOR THE DEVICE TO OPEN. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, FIRST CUTTER COULD ONLY BE OPENED WITH APPLICATION OF EXCESSIVE FORCE, ANASTOMOSIS WAS INCOMPLETE. THE SECOND CUTTER COULD ONLY BE FIRED WITH APPLICATION OF EXCESSIVE FORCE. THIS HAPPENED DUE TO THE ANATOMY OF THE SURGEON. A REALLY BIG MAN (MORE THAN 2 METERS HEIGHT) AND REALLY BIG HANDS. THE INSTRUMENT BROKE AFTER FIRING. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON* 60 ENDOPATH** STAPLER LONG ENDOSCOPIC LINEAR CUTTER - STRAIGHT 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1