BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 1914905 · Received December 6, 2010

    Report

    Report Number
    1527736-2010-00114
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PREMATURE SLED MOVEMENT THE EC60A DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH THREE RELOADS PRESENT. THE RELOADS WERE RECEIVED PARTIALLY FIRED 1/16. 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. THE RETURNED CARTRIDGE RELOADS WERE TESTED FOR FUNCTIONALITY IN THE STRAIGHT AND ARTICULATED POSITIONS BY RESETTING AND RELOADING IT INTO THE DEVICE. THE RELOADS WERE LOADED INTO THE DEVICE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE ACHIEVED ITS COMPLETE STROKE 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 CUTS WERE 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. THE DEVICE OPENED AND CLOSED AS INTENDED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    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 SLEEVE GASTRECTOMY PROCEDURE, IN THE FIRST FIRING WITH A GREEN RELOAD AND WITHOUT ARTICULATING THE DEVICE, THE SURGEON FELT MORE FORCE TO CLOSE THAN USUAL. WHEN HE FIRED THE INSTRUMENT, THE STAPLE LINE WAS INCOMPLETE BECAUSE HE NEEDED SUCH STRENGTH TO FIRE THAT HE STOPPED. HERE HE FELT SOME DIFFICULTIES IN OPENING THE INSTRUMENT TOO. IN THE SECOND FIRE, HE USED ANOTHER GREEN RELOAD, AND EVERYTHING WENT WELL. IN THE THIRD AND FOURTH FIRINGS HE FELT, AGAIN, SOME HIGHER FORCE TO CLOSE, TO FIRE AND TO OPEN THE INSTRUMENT. THE SCRUB NURSE REPORTED ALSO THAT WHEN SHE WAS RELOADING THE INSTRUMENT, THE RELOADS WERE MORE LOOSE THAN USUAL. THEY REPLACED THE INSTRUMENT AFTER THOSE EVENTS, AND NO MORE PROBLEMS OCCURRED. ALSO, ONE OF THEM FELL INTO THE ABDOMEN WHEN THEY WERE TRYING TO PLACE THE INSTRUMENT. AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THIS DEVICE, THE PROCEDURE WAS PROLONGED 15 MINUTES. THE CONDITION OF THE PATIENT IMMEDIATELY FOLLOWING THE EVENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK G4TW5M

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR (B)(4)