BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3041332 · Received April 8, 2013

    Report

    Report Number
    3005075853-2013-01648
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PREMATURE SLED MOVEMENT, DAMAGED RELEASE BUTTON. THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH THE MANUAL OVERRIDE DOOR OUT OF POSITION AND MISSING; THE OVERRIDE LEVER WAS UP WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. IT SHOULD BE NOTED AFTER THE MANUAL OVERRIDE SYSTEM IS USED THE INSTRUMENT IS DISABLED AND CANNOT BE USED FOR ANY SUBSEQUENCE FIRINGS. IN ADDITION, THE KNIFE WAS NOT FULLY RETRACTED, THUS THE DEVICE WOULD NOT OPEN. A CARTRIDGE PARTIALLY FIRED 1/16 WAS LOADED IN THE DEVICE. 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. FURTHERMORE, THE DEVICE WAS FOUND TO HAVE THE CLAMPING MECHANISM DAMAGED. DUE TO THE WEAR AND DAMAGE TO THE CLAMP RELEASE, IT APPEARS THAT THE DEVICE WAS FORCED OPEN WHEN THE KNIFE WAS NOT IN THE HOME POSITION. THE DEVICE WAS DISASSEMBLED TO RESET THE BAILOUT SYSTEM AND THEN, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE 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 PROPERLY. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION RECEIVED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? PULMONARY. VEIN / DIRECTLY ACROSS IT. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 2ND. WHAT COLOR CARTRIDGE WAS BEING USED? WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WHITE. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NEAR, BUT NOT ON. WERE ANY UNEXPECTED NOISES HEARD? YES, POWER IMMEDIATELY STOPPED AFTER INITIATING. AFTER THE DEVICE WAS REMOVED FROM TISSUE WAS THERE ANY TISSUE DAMAGE? IF SO, HOW WAS THE TISSUE REPAIRED? NO. STAPLES AND BLADE HAD NOT MADE CONTACT WITH VESSEL YET, THOUGH JAWS WOULDN'T OPEN FROM VESSEL. COMPLETED CASE AFTER REMOVING STAPLER WITH ANOTHER SAME LIKE DEVICE WITH NO ISSUES. THE DEVICE WAS REMOVED BY FORCIBLE BRINGING THE HANDLES OPEN TO REMOVE THE DEVICE FROM THE TISSUE. THE JAWS DID NOT FULLY OPEN IT ONLY OPENED A FEW MM, ENOUGH TO REMOVE FROM TISSUE. THERE WAS NO TISSUE DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE IS STUCK ON AN ARTERY AND WILL NOT OPEN. WHEN CUSTOMER SUPPORT ADVOCATE CAME ON THE PHONE, THEY HAD ALREADY REMOVED THE BATTERY AND USED THE "MANUAL OVERRIDE" HANDLE. THE CUSTOMER SUPPORT ADVOCATE ADVISED TO KEEP PULLING ON THE HANDLE UNTIL IT STOPS MOVING AND THEN THE KNIFE IS IN THE HOME POSITION. AT THAT TIME, IT WAS REPORTED THEY WERE ABLE TO PRY OPEN THE HANDLES ENOUGH TO OPEN THE JAW AND REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143253 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1