BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECEHLON LINEAR CUTTER

    MDR report key: 3864261 · Received June 10, 2014

    Report

    Report Number
    3005075853-2014-03903
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 18, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HOW LONG WAS THE PROCEDURE PROLONGED? 10 MIN. HOW WAS THE PROCEDURE COMPLETED? AS USUAL, HE HAD TO CHANGE THE STAPLER (GET RID OF THIS ONE AND OPEN A NEW ONE) AND THE RELOAD AND GO ON WITH THE STAPLING OF THE STOMACH, EVEN IF THE TISSUES WERE A LITTLE DAMAGED. WAS THERE ANY PATIENT CONSEQUENCE AS A RESULT OF THE EVENT? NO. WAS THE POST-OPERATIVE CARE OF THE PATIENT CHANGED AS A RESULT OF THE EVENT? NO. WAS THERE ANY OTHER ISSUE NOTED WITH STAPLE LINE OTHER THAN BLEEDING? SOME STAPLES WERE MALFORMED. HOW MUCH BLOOD WAS LOST (ML)? 0. DID THE PATIENT REQUIRE A TRANSFUSION? NO. WHAT COLOR CARTRIDGE WAS BEING USED? GOLD. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? HE DID A SUTURE WITH A VLOC. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO THE. INSTRUMENT WAS FIRED IN THE CONTINUITY OF THE PREVIOUS STAPLE LINE BUT WAS NOT USE ON ANY STAPLE OR STAPLE LINES. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING OR OPENING)? NO.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR60D CARTRIDGE LOADED ON THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND 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. THE EVENT COULD NOT BE CONFIRMED AS NO CUTTING ISSUES WERE NOTED DURING FUNCTIONAL TESTING. NO MALFORMED STAPLES WERE NOTED. 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. 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 A VERTICAL BANDED GASTROPLASTY PROCEDURE, WHEN CUTTING THE STOMACH-INTERVENTION LONGITUDINAL GASTROPLASTY AFTER CLOSING THE CLAMP (AT THE FOURTH CARTRIDGE) FOR STAPLING TISSUE, THE SURGEON STARTED THE TRAINING OF MOTORIZED BLADE. THE BLADE DOES NOT CUT PROPERLY THE TISSUE, BUT CREATES A TEARING OF THE TISSUE OF THE WALL OF THE STOMACH WITHOUT THE GASTRIC BAG OPENING. THE INTERVENTION WAS LONGER. HEMORRHAGE LARGEST AT THE STAPLING LINE ON THE REMAINING STOMACH. THERE WAS A RISK OF COMPLICATIONS HIGHER FISTULA. UNKNOWN HOW CASE WAS COMPLETED. SURGERY WAS PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337626 ECEHLON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DT2J

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60D