BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 1160568 · Received September 11, 2008

    Report

    Report Number
    3005075853-2008-01636
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 4, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DAMAGED ARTICULATION GEAR. EVALUATION SUMMARY: THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED WITH FULLY FIRED RELOAD IN THE DEVICE AND WITH THE ARTICULATION MECHANISM DAMAGED AS THE ARTICULATION GEAR AND LEVER WERE DETACHED FROM THE DEVICE. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY ONLY IN THE CENTER POSITION DUE TO THE DAMAGED ARTICULATION GEAR WITH A TEST RELOAD AND IT FIRED, CUT, AND ALL THE STAPLES FORMED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETED, AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED FGQA. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VATS PROCEDURE, ON THE FIFTH FIRING THE ARTICULATION KNOB BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG LNR CUTR 45MM GDW ETHICON ENDO-SURGERY, LLC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1