BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4120552 · Received September 26, 2014

    Report

    Report Number
    3005075853-2014-06690
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH AN CARTRIDGE LOADED ON THE DEVICE. THE RETURNED RELOAD WAS FULLY FIRED AND DAMAGE ON CARTRIDGE DECK WAS NOTED. THE DAMAGE TO THE CARTRIDGE IS CONSISTENT WITH THE DEVICE BEING FIRED OVER AN ALREADY EXISTING STAPLE LINE; WHEN THIS HAPPENS THE KNIFE PLOWS THE STAPLES ON CARTRIDGE DECK AND SHAVING MAY OCCUR. 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 WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND IT 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. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SMALL ABDOMINAL SECTION OF LOBECTOMY, IN THE 1ST DEVICE, THE TARGET TISSUE SLIPPED FORWARD AND THE STAPLES WERE PARTIALLY DEPLOYED AT THE 4TH FIRING ON THE BLOOD VESSEL. THEN, THE SAME DEVICE WAS FIRED ON THE INTERLOBAR AT THE 5TH FIRING, BUT THE STAPLES WERE NOT FORMED PROPERLY. IN THE 2ND DEVICE, IT COULD NOT BE FIRED AT THE 1ST FIRING. THE CARTRIDGE WAS GOLD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE 2ND DEVICE COULD BE FIRED WHEN THE BATTERY OF THE 1ST DEVICE WAS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600334 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4ET94

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD: ECR45B, ECR45D