BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2111527 · Received June 2, 2011

    Report

    Report Number
    3005075853-2011-02241
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 13, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RELEASE BUTTON THE SC60 DEVICE WAS RETURNED WITH THE ANVIL AND THE CLOSING TRIGGER IN THE CLOSED POSITION. THE DEVICE WAS RECEIVED WITH A PARTIALLY FIRED RELOAD PRESENT. AFTER FURTHER ANALYSIS THE 3 STOKE INDICATOR WAS AT POSITION III AND THE KNIFE WAS NOTED TO BE AT THE HOME POSITION. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITIONS OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE LEFT SIDE RELEASE BUTTON POST WAS NOTED TO BE BROKEN, IN ADDITION THE IDLER GEAR WAS NOTED TO HAVE TEETH DAMAGE AND THE IDLER GEAR AND INDICATOR GEAR WERE NOT SYNCHRONIZED. THE DAMAGE FOUND 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 IDLER GEAR WILL BECOME DAMAGE RESULTING IN THE GEAR SKIPPING DAMAGING THE TEETH AND GETTING OUT OF SYNCHRONIZATION WITH THE INDICATOR GEAR. WHEN THE GEARS GET OUT OF SYNCHRONIZATION AT THE MOMENT THE KNIFE IS HOME THE INDICATOR GEAR WILL BE AT A DIFFERENT POSITION NOT ALLOWING THE DEVICE TO OPEN. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL FOLLOWUP: AFTER THE OPERATION, THE SALES REP CHECKED THE DEVICE CONDITION WITH THE DOCTOR. THE JAWS WERE CLOSED. THE STAPLE DRIVERS WERE DEPLOYED TILL 4CM SCALE ON THE JAWS AND THE KNIFE WAS RETURNED TO THE HOME POSITION. THE MANUAL RELEASE LEVER COULD BE PULLED UP. THE REP PUSHED THE RELEASE BUTTON SEVERAL TIMES, BUT STILL THE JAW DID NOT OPEN. FINALLY THE DOCTOR OPENED THE JAWS FORCIBLY BY USING A PEAN FORCEPS. THE DOCTOR COMMENTED THAT IT HAD A DIFFICULTY IN FIRING. NO BLEEDING OCCURRED. THE DEVICE WAS USED ON THE RECTUM. THE TARGET TISSUE WAS THICK. THE DEVICE DID NOT FIRE ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP. THERE WERE NO DIFFICULTY IN CLOSING. REINFORCEMENT MATERIAL WAS NOT USED. THE 4 DEPLOYED STAPLES WERE B-FORMED ON THE SAMPLE OF TISSUE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, FIRST THE DOCTOR ADJUSTED THE FIRING POSITION ON THE TARGET TISSUE FIVE TIMES BY CLOSING/OPENING THE CLOSING LEVER. SECONDLY, THE DEVICE WAS FIRED BUT A RASPING SOUND WAS HEARD AT THE 1ST STROKE OF THE 1ST FIRING. THE MANUAL RELEASE LEVER WAS PULLED UP TO RELEASE THE JAWS, BUT THE MANUAL RELEASE LEVER COULD NOT BE PULLED UP. AS THE DOCTOR THOUGHT THAT THE JAWS MIGHT BE OPENED IF THE FIRING TRIGGER WAS GRASPED AGAIN, THE FIRING TRIGGER WAS GRASPED. BUT, A RASPING SOUND WAS HEARD AND THE JAWS DID NOT OPEN. BESIDES, THE RELEASE BUTTON COULD NOT WORK. WHEN THE DOCTOR PULLED UP THE MANUAL RELEASE LEVER SEVERAL TIMES, THE MANUAL RELEASE LEVER BECAME TO BE PULLED UP SOMEHOW. HOWEVER, THE JAW STILL DID NOT OPEN. FINALLY, THE ANUS SIDE OF THE TISSUE WAS DENUDED AND ANOTHER NEW DEVICE WAS FIRED AT THE ANUS SIDE TO REMOVE THE DEVICE AND THE CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H4383E

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60D