BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX ENDOSCOPIC ARTICULATING LINEAR CUTTER (STANDARD) - 35 MM

    MDR report key: 1160566 · Received September 11, 2008

    Report

    Report Number
    3005075853-2008-01640
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: TWO DEVICES WERE RETURNED FOR ANALYSIS. DEVICE A WAS RETURNED IN GOOD VISUAL CONDITION, WITH THREE RELOADS PRESENT. RELOAD C WAS RECEIVED VOID OF STAPLES, HOWEVER RELOADS D AND E RECEIVED FULLY LOADED WITH STAPLES. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOADS D AND E, THE DEVICE FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITH OUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE RELOADS WERE LOADED WITHOUT ANY DIFFICULTIES AND DID NOT FALL OUT DURING TESTING. DEVICE B WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE, IN ADDITION THE RELOAD DID NOT FALL OUT DURING TESTING. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. ADDITIONAL INFO ON DEVICE B: BATCH #= E5P397. EXPIRATION DATE: 05/2013. MANUFACTURING DATE: 06/2008.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT DURING A LAP APPENDECTOMY PROCEDURE, WHEN THE SURGEON FIRED THE DEVICE, THE CARTRIDGE FELL OUT OF THE DEVICE AND INTO THE ABDOMINAL CAVITY. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX ENDOSCOPIC ARTICULATING LINEAR CUTTER (STANDARD) - 35 MM GDW ETHICON ENDO-SURGERY, LLC. NA E4L077

    Patients

    Seq Age Sex Outcome Treatment
    1