BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR

    MDR report key: 725970 · Received June 8, 2006

    Report

    Report Number
    1527736-2006-02611
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Report Date
    April 6, 2006
    Manufacturer
    ETHICON ENDO-SURGERY, INC.(CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE WAS RECEIVED FULLY LOADED WITH STAPLES. THE RETURNED DEVICE WAS FOUND TO BE NON FUNCTIONAL AS THE FIRING MECHANISM WAS NOTED TO BE DAMAGED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITIONS OF THE DEVICE. 510(K) IS K020779.

    Description of Event or Problem · 1

    DURING A THORACOTOMY PROCEDURE, THE DEVICE WOULD NOT FIRE ON SECOND USE. OPENED A NEW ONE TO COMPLETE PROCEDURE. NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR GDW GCJ ETHICON ENDO-SURGERY, INC.(CINCINNATI) NA C4D043

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN