BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2121005 · Received June 13, 2011

    Report

    Report Number
    3005075853-2011-02375
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT A: INCOMPLETE/INTERRUPTED CYCLE. THE EC60A DEVICE (A) WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH A CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED AND WITH SEVERAL STAPLES ON THE CARTRIDGE DECK. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION USING 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. EVENT COULD NOT BE CONFIRMED AS THE KNIFE WORKED PROPERLY AND NO NOISE WAS HEARD DURING THE ANALYSIS. THE ANALYSIS FOUND THAT THE EC60A DEVICE (B) WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH AN ECR60G RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED AND WITH SEVERAL B-FORMED STAPLES ON THE CARTRIDGE DECK. IN ADDITION, SEVERAL CLUSTERS OF STAPLES WERE RECEIVED IN A SMALL BAG. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND IT FIRED, AND FORMED ALL THE STAPLES AS INTENDED. THE CUT WAS NOTED TO BE JAGGED DUE TO A DAMAGED KNIFE. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE TO THE KNIFE IS WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. REPEATEDLY FIRING ACROSS EXISTING STAPLE LINES CAN ALSO REDUCE THE ABILITY TO CUT CLEANLY. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, THE FIRST INSTRUMENT LOADED WITH A GREEN CARTRIDGE CLAMPED WITH QUITE THICK LUNG PARENCHYMA AND FIRED AT THE 1ST FIRING. ALTHOUGH THE FIRING TRIGGER COULD BE GRASPED TILL THE SECOND STROKE OF THE 1ST FIRING, THE DEVICE WAS LOCKED AND THE GRASPING FORCE OF THE FIRING TRIGGER WAS LOWER THAN USUAL. THEN A MANUAL KNIFE REVERSE SWITCH WAS PUSHED TO RETURN THE KNIFE TO THE HOME POSITION AND THE DEVICE WAS RELEASED. THE PROXIMAL PARTS OF THE STAPLE LINE WERE MALFORMED. WHEN THE INSTRUMENT WAS FIRED TO CHECK ITS FUNCTION WITHOUT CLAMPING THE TISSUE, THE FIRING TRIGGER COULD BE GRASPED. HOWEVER AN ABNORMAL SOUND LIKE A SPRING SPREAD WAS HEARD. THEN THE SECOND INSTRUMENT LOADED WITH A GREEN CARTRIDGE WAS FIRED AT THE 1ST FIRING. ALTHOUGH THE FIRING TRIGGER COULD BE GRASPED TILL THE THIRD STROKE OF THE 1ST FIRING, THE KNIFE DIRECTION DID NOT CHANGE TO RETURN MODE AND THE DEVICE WAS LOCKED OUT. THE CLAMPED TISSUE WAS DROPPED BEFORE OPENING THE JAWS. AS THE DEPLOYED STAPLES WERE PROPER B-FORMED, THE OPERATION WAS FINISHED WITHOUT ANY ADDITIONAL TREATMENT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43C10

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)