BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 3202557 · Received July 2, 2013

    Report

    Report Number
    3005075853-2013-03389
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 14, 2013
    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). THE ANALYSIS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH AN ECR60W CARTRIDGE LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED. 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. THE KNIFE REVERSE FEATURE WORKED AS INTENDED. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. 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. 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HOW MUCH TISSUE WAS RESECTED TO REMOVE THE DEVICE (SPECIFY IN CM)? ---ABOUT 3 CM. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? ---ONLY WHITE CARTRIDGES WERE USED. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ---NO. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? ---NO. AS OF NOW, THE PATIENT¿S CONDITION IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN TOTAL GASTRECTOMY, THE JAWS DID NOT OPEN AFTER 4TH STROKE OF THE 4TH FIRING ON THE SMALL BOWEL. ALTHOUGH THE MANUAL KNIFE REVERSE SWITCH WAS USED AND THE TRIGGER WAS GRASPED SEVERAL TIMES, THE JAWS DID NOT OPEN. EVENTUALLY, THE DEVICE WAS REMOVED FROM THE PATIENT BY CUTTING OFF BOTH SIDES OF JAWS. AT THE 4TH FIRING, THERE WAS NEITHER UNEXPECTED NOISE NOR RESISTANCE WHILE CLOSING AND FIRING. THE CARTRIDGE WAS WHITE. REINFORCEMENT MATERIAL WAS NOT USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300888 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

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