BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH

    MDR report key: 3200138 · Received July 1, 2013

    Report

    Report Number
    3005075853-2013-03378
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 24, 2013
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. DAMAGED ANVIL. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE DEVICE WAS USED IN PULMONARY LOBE RESECTION. THE DEVICE WAS USED ON LUNG FISSURE. THE TISSUE WAS NOT CUT, AND ONLY SOME STAPLES CAME OUT. THE SURGEON STOPPED FIRING AFTER 1ST STROCK. THE ANALYSIS RESULTS FOUND THAT ONE DEVICE WAS RETURNED WITH THE ANVIL BENT UPWARDS AND WITHOUT RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE 3-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. HOWEVER, THE CUT WAS JAGGED DUE TO A DAMAGED KNIFE. ONE POSSIBLE CAUSE FOR THE DAMAGED KNIFE MAY BE IF 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. IT IS RECOMMENDED THAT 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. IT IS POSSIBLE THAT THE DEVICE WAS CLAMPED OVER AN EXCESS OF TISSUE CAUSING THE ANVIL TO BENT AND FOR THE FIRING STROKE AND THE STAPLE FORM TO BE INCOMPLETE. ADDITIONALLY PLEASE ENSURE THAT THE TISSUE LIES FLAT AND IS POSITIONED PROPERLY BETWEEN THE JAWS. ANY BUNCHING OF TISSUE ALONG THE RELOAD, PARTICULARLY IN THE CROTCH OF THE JAWS, MAY RESULT IN AN INCOMPLETE STAPLE LINE. 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). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TISSUE WAS PUSHED OUT OF THE JAW WHEN THE CLOSING FIRING TRIGGER. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299368 ECHELON 60 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CJ0K

    Patients

    Seq Age Sex Outcome Treatment
    1