BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4110291 · Received September 23, 2014

    Report

    Report Number
    3005075853-2014-06616
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 11, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HOW LONG WAS THE PROCEDURE PROLONGED? 45MIN. WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT? > NOT YET. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? > BLACK. BLACK. NONE AFTER. STAPLER SWITCHED. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? > YES. GORE SEAMGUARD. WERE ANY UNEXPECTED NOISES HEARD? NO. IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING OR OPENING)? NO. WHAT WAS THE PATIENT S BMI AND GENDER? (B)(6), FEMALE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH AN ECR60G CARTRIDGE LOADED IN THE DEVICE. ADDITIONALLY, THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED, LEFT SIDE OUTER ROW FULLY FIRED AND THE LEFT TWO INNER ROWS PARTIALLY FIRED 1/4. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. AS ADDITIONAL TESTING, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, ON THE THIRD FIRING ONLY ONE OF THE THREE STAPLE LINES FORMED ON THE SLEEVE SIDE. THE SURGEON HAD TO OVER SEW IT. ALL OTHER FIRINGS SEEMED NORMAL. THE TISSUE SOUNDED THICK BUT NO PROBLEM WAS OBVIOUS TILL THE STAPLER WAS DONE FIRING. NO ANATOMICAL ANOMALIES. IT'S TOO SOON TO TELL IF THERE ARE NEGATIVE OUTCOMES. THE CASE LASTED LONGER DUE TO OVER SEWING. GORE SEAM GUARD USED ON FIRING. THE PATIENT'S SWALLOW TEST THE NEXT DAY WAS FINE, BUT THE SURGEON NOTED THE SLEEVE WAS A LITTLE TIGHTER WHERE HE HAD TO OVER SEW. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592240 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60G