BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE LINE - 2.

    MDR report key: 1810041 · Received November 12, 2007

    Report

    Report Number
    1527736-2007-07502
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    September 18, 2007
    Report Date
    September 19, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DAMAGED FIRING TRIGGER TEETH. 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. IN ADDITION TWO CARTRIDGES WERE RECEIVED INSIDE THE BAG, CARTRIDGE B WAS RECEIVED PARTIALLY FIRED AND WITH THE LOCKOUT DAMAGED. THE DAMAGE TO THE SPRING CARTRIDGE LOCKOUT IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. IN ADDITION, THE INSTRUCTIONS FOR USE STATE, "THE FIRING STROKE MUST BE COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. NOTE: ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE." CARTRIDGE C WAS RECEIVED UNFIRED. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. THE RETURNED CARTRIDGES WERE TESTED FOR FUNCTIONALITY WITH A TEST DEVICE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, THE DEVICE COULD NOT FIRE. COMPETITIVE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE LINE - 2. GDW ETHICON ENDO-SURGERY, INC (CINCINNATI) NA

    Patients

    Seq Age Sex Outcome Treatment
    1