BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS-FLEX45 ARTICULATING ENDOSCOPIC LINEAR

    MDR report key: 728390 · Received June 15, 2006

    Report

    Report Number
    1527736-2006-02732
    Event Type
    Malfunction
    Date Received
    June 15, 2006
    Date of Event
    March 23, 2006
    Report Date
    April 12, 2006
    Manufacturer
    ETHICON ENDO SURGERY, INC.(CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    k020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: FIRING MECHANISM DAMAGED. EVALUATION SUMMARY: THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE WAS RECEIVED PARTIALLY FIRED AND WITH NO DAMAGED TO THE CARTRIDGE LOCK OUT TAB. 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; THE FIRING TRIGGER TEETH WERE FOUND DAMAGE AND THE LEFT SHROUD PINION AXLE SUPPORT WAS FOUND BROKEN. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. 510(K) NUMBER IS K020779.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC GASTRIC BYPASS ROUX-EN-Y PROCEDURE, THE DEVICE BROKE ON THE THIRD FIRING. NO PT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN