BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER

    MDR report key: 726067 · Received June 8, 2006

    Report

    Report Number
    1527736-2006-02610
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Date of Event
    June 15, 2005
    Report Date
    June 20, 2005
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BASED ON THE ANALYSIS FINDINS OF DAMAGED PINION AXLE AND DAMAGED FIRING TRIGGER TEETH, THIS EVENT IS CONSIDERED TO BE REPORTABLE. 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 DAMAGE 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 LEFT SHROUD PINION AXLE SUPPORT WAS FOUND DAMAGED AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. 510(K) IS K020779

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, WHEN HE WAS MAKING POUCH AFTER ABOUT 4 FIRINGS ON THE STOMACH HE NOTICED THAT THE STAPLER FELT FUNNY WHEN HE FIRED IT. WHEN HE CHECKED THE STAPLE LINE HE SAW THAT THE STAPLES FIRED BUT DID NOT CUT. HE THEN FIRED AGAIN WITH ANOTHER GUN AND THE SAM3E THING HAPPENED ANOTHER SHORT FIRE. HE THEN OPENED ANOTHER GUN AND FIRED AGAIN, THIS TIME THE STAPLER WORKED FINE. THERE WAS NO PT CONSEQUENCES. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN