BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3935296 · Received July 15, 2014

    Report

    Report Number
    3005075853-2014-04957
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 30, 2014
    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
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HOW MUCH BLOOD WAS LOST (ML)? NO EXTRA ABNORMAL LOSS IS TO MENTION DUE TO THE INCIDENT DID THE PATIENT REQUIRE ANY TYPE OF INTERVENTION BASED ON THE BLOOD LOSS? IF YES, EXPLAIN. NO. COULD THE FOURTH STROKE NOT BE DONE TO RETURN THE KNIFE BLADE? 4TH STROKE NOT COMPLETED, GUN STUCK. DID THE POST-OPERATIVE CARE CHANGE BASED ON THE EVENT? NO. WHAT IS THE CURRENT PATIENT STATUS? STABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED INSERTED THROUGH A TROCAR, WITH THE CLOSING TRIGGER AND ANVIL IN THE CLOSED POSITION, AND THE FIRING MECHANISM IN THE RETURN STROKE WITH THE KNIFE NOT FULLY BACK. A CARTRIDGE RELOAD WAS LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. IN ADDITION, A CLIP WAS FOUND LODGED BEHIND THE KNIFE, RESULTING IN THE FIRING MECHANISMS JAMMING. 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. FIRING THE DEVICE WITH A CLIP IN THE JAWS CAN JAM THE FIRING MECHANISM RESULTING IN THE DEVICE NOT OPENED. THE CLIP WAS REMOVED AND THE KNIFE WAS FULLY RETURNED BY COMPLETING THE RETURN STROKE. NO FURTHER FUNCTIONAL TESTING WAS MADE. IN ADDITION IN ORDER TO VERIFY THE INTEGRITY OF INTERNAL COMPONENTS THE RETURNED DEVICE WAS DISASSEMBLED AND NO ANOMALIES WERE NOTED. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHILE DOING THE THIRD FIRING WITH GREEN RELOAD, THE KNIFE DIDN'T GET BACK AFTER THE THREE PLASTIC TO PLASTIC MOVEMENTS, LOCK SIGN APPEARED AND THE STAPLER GOT STUCK. ALL ATTEMPTS FAILED TO OPEN THE STAPLER. THE DOCTOR TRIED TO RETURN THE KNIFE USING A MARYLAND BUT NOTHING COULD OPEN THE DEVICE . ANOTHER DEVICE WAS USED, LATERAL TO THE FIRST, STOMACH CUT AND PROCEDURE CONTINUED. STAPLERS AT THE SITE OF INCIDENT WHERE STABLE, BUT THEY REINFORCED THEM WITH STITCHES. PROCEDURE HAPPENED ON SATURDAY (DAY OFF), ASSISTANCE WAS MADE OVER THE PHONE. DEFECTIVE DEVICE IS STILL THERE UNTIL YOU PRECISE THE WAY OF DECONTAMINATION, SINCE IT CONTAINS LIVE TISSUE. THERE WAS BLEEDING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413617 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DK8J

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60G