BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4090499 · Received September 15, 2014

    Report

    Report Number
    3005075853-2014-06430
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE PSE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD PRESENT. THE MANUAL OVERRIDE DOOR WAS NOTED TO BE OUT OF POSITION; THE OVERRIDE LEVER WAS UP WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. IT SHOULD BE NOTED AFTER THE MANUAL OVERRIDE SYSTEM IS USED THE INSTRUMENT IS DISABLED AND CANNOT BE USED FOR ANY SUBSEQUENCE FIRINGS. THE DEVICE WAS DISASSEMBLED TO RESET THE MANUAL OVERRIDE SYSTEM; THE INSTRUMENT 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 REPORTED DAMAGED MANUAL OVERRIDE DOOR EVENT COULD NOT BE CONFIRMED AS NO DAMAGE WAS FOUND DURING VISUAL INSPECTION. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN REMOVED FROM PACKAGE, THE CAP ON THE MANUAL OVERRIDE CAME OFF OF THE DEVICE. THIS PRODUCT WAS NEVER USED ON PATIENT. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570191 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EY4F

    Patients

    Seq Age Sex Outcome Treatment
    1