BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 4

    MDR report key: 1170355 · Received September 12, 2008

    Report

    Report Number
    3005075853-2008-01666
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 26, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DAMAGED FIRING TRIGGER TEETH. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A PARTIALLY RELOAD ON THE DEVICE. THE CARTRIDGE LOCK OUT TAB WAS BENT. THE DAMAGE TO THE CARTRIDGE LOCKOUT TAB IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. WHEN FIRING THE DEVICE, MAKE SURE THAT THE FIRING STROKE IS COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. 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. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. 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. 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 AN UNKNOWN PROCEDURE, THE DEVICE COULD NOT CUT THE TISSUE. THE SURGEON CHANGED TO ANOTHER RELOAD, BUT IT STILL COULD NOT CUT THE TISSUE. THE SURGEON USED ANOTHER SAME LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 4 GDW ETHICON ENDO-SURGERY, LLC. NA E4K47Y

    Patients

    Seq Age Sex Outcome Treatment
    1