BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS COMPACT FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER FOR OPEN PROCE

    MDR report key: 1823915 · Received January 16, 2008

    Report

    Report Number
    1527736-2008-00313
    Event Type
    Malfunction
    Date Received
    January 16, 2008
    Date of Event
    August 24, 2007
    Report Date
    November 20, 2007
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH AN SUFFICIENT H-CRIMP, WITH THE FIRING MECHANISMS DAMAGED AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE WAS RECEIVED FULLY LOADED WITH STAPLES. NO FUNCTIONAL TEST COULD BE PERFORMED WITH THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. THE RETURNED CARTRIDGE WAS LOADED INTO A TEST DEVICE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. ALTHOUGH NO CONCLUSION COULD BE REACHED ON HOW THE DEVICE GOT DAMAGED WITH THE INFO PROVIDED, IT SHOULD BE NOTED THAT AT LEAST A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LOCKED AND DID NOT FIRE. COMPLETED WITH THE SAME LIKE PRODUCT. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS COMPACT FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER FOR OPEN PROCE GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA C4EH7L

    Patients

    Seq Age Sex Outcome Treatment
    1