BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4090228 · Received September 15, 2014

    Report

    Report Number
    3005075853-2014-06421
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 29, 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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID THE DEVICE DELIVER ANY STAPLES. --- YES, THE KNIFE SLIGHTLY MOVED FORWARD AND A FEW STAPLES OF PROXIMAL END WERE DEPLOYED. IF YES, WERE THE STAPLES FORMED PROPERLY. --- NO. IF YES, WAS THE STAPLE LINE COMPLETE. --- NO.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT ONE PSE60A DEVICE WAS RETURNED WITH THE ANVIL BENT UPWARDS AND WITH AN ECR60G CARTRIDGE LOADED ON THE DEVICE. THE RETURNED RELOAD WAS FULLY FIRED AND DAMAGE ON DECK WAS NOTED. THE FOUND DAMAGE ON THE DECK IS CONSISTENT WHEN THE DEVICE IS 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 NOT TESTED FOR FUNCTIONALITY DUE TO THE CONDITION OF THE ANVIL, HOWEVER THE DEVICE WAS DRY FIRED TO TEST THE CONDITION OF THE FIRING MECHANISM AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE FOUND CONDITION OF THE ANVIL MAY LEAD MALFORMED STAPLES OR INCOMPLETE STAPLE LINES. 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 OPEN LOW ANTERIOR RESECTION, THE KNIFE OF THE 1ST DEVICE STOPPED AFTER MOVING A FEW MILLIMETERS AT THE 1ST FIRING, AND THEN IT DID NOT MOVE FORWARD THOUGH THE FIRING TRIGGER WAS GRASPED SEVERAL TIMES. THE 2ND DEVICE COULD BE FIRED WITHOUT PROBLEM AT THE 1ST FIRING. HOWEVER, THE KNIFE OF THE 2ND DEVICE STOPPED AT THE 2ND FIRING AS THE EVENT IN THE 1ST DEVICE. THE KNIVES OF THE 1ST AND 2ND DEVICES WERE RETURNED WITH THE KNIFE REVERSE SWITCH. THE DEVICES WERE USED ON THE RECTUM. AS THERE WAS THE MESORECTUM, THE TARGET TISSUE WAS THICK. EVENTUALLY, A COMPETITOR'S WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AFTER THIS INCIDENT, A NURSE TRIED TO FIRE THE 1ST DEVICE OUT OF THE PATIENT, AND THE MANUAL OVERRIDE LEVER WAS USED. WHEN THE SALES REP FIRED THE 2ND DEVICE, IT FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568359 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4ER7P

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60G (LOT#:L4EA6U) X2