BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2180234 · Received July 27, 2011

    Report

    Report Number
    3005075853-2011-03015
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 29, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JAMMED KNIFE, IDLER GEAR. THE ANALYSIS RESULTS FOUND THAT ONE EC60 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH A FULLY FIRED RELOAD PRESENT. THE CARTRIDGE DECK WAS FOUND DAMAGED AND SEVERAL B-FORM STAPLES WERE NOTED TO BE ON THE CARTRIDGE DECK. IN ADDITION A BROKEN CLIP WAS FOUND INSIDE ON THE JAWS. AFTER FURTHER ANALYSIS, 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 NOT AT THE HOME POSITION; NO FUNCTIONAL TEST COULD BE PERFORMED. THE DAMAGE TO THE CARTRIDGE DECK IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER A HARD OBJECT. WHEN PLACING THE INSTRUMENT ON THE TISSUE TO BE STAPLED, ENSURE THAT NO HARD OBSTRUCTION (SUCH AS A CLIP) IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. FIRING TROUGH A HARD OBJECT CAN JAM THE DEVICE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR WARNINGS AND PRECAUTION REGARDING FIRING ACROSS HARD OBJECTS. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE INDICATOR GEAR TEETH AND THE SEVERAL IDLER GEAR TEETH WERE NOTED TO BE DAMAGED, IN ADDITION THE BACK OF THE KNIFE WAS NOTED TO BE KNICK. THIS IS CONSISTENT WITH ATTEMPTING TO RETURN A JAMMED KNIFE WITH THE MANUAL RELEASE LEVER. IF THE KNIFE IS JAMMED DUE TO A CLIP, THE FIRING MECHANISM WILL BE BLOCK AND IF ENOUGH FORCE IS APPLIED TO THE MANUAL RELEASE LEVER IN ATTEMPT TO RETURN THE JAMMED KNIFE CAN RESULT IN THE DAMAGE IN DE-SYNCHRONIZATION OF THE GEARS AND CONSEQUENTLY THE DEVICE WILL NOT OPEN. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WEDGE RESECTION PROCEDURE, THE JAWS WOULD NOT OPEN ONCE FIRED ON LUNG TISSUE. ANOTHER DEVICE WAS USED TO CUT IT OFF THE TISSUE. ONCE OFF THE TISSUE, THE JAWS OF THE DEVICE WERE PRIED OPEN TO PULL THE TISSUE SAMPLE OUT FOR PATHOLOGY. A CLIP WAS ALSO PULLED FROM THE JAWS. THE SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? LUNG. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? ASKU. DURING WHICH STROKE DID THE EVENT OCCUR? UNK. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? ASKU. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? ASKU CLOSING AND FIRING, WOULD NOT OPEN. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? ABLE TO GET THE BLADE FULLY RETRACTED, THEN TO PRY THE JAW OPEN ENOUGH TO PULL SPECIMEN OUT. USED THE CRANK, THE JAWS WOULD NOT OPEN. THE FIRING INDICATOR WAS NOT BACK AT ZERO EVEN THROUGH THE KNIFE BLADE WAS FULLY RETRACTED. ABLE TO GET THE RETRACTION TO PUSH BACK AND IT WOULD MOVE THE KNOB EVEN THROUGH THE KNIFE BLADE WAS FULLY BACK. FINALLY GOT IT TO OPEN BUT HAD TO CLOSE THE HANDLE A LITTLE. BY DOING THAT THE KNIFE BLADE WOULD MOVE FORWARD BUT THEN THE HANDLES WOULD OPEN UP. THE GEARS WERE OFF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1