BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH EXCEL

    MDR report key: 1071465 · Received July 2, 2008

    Report

    Report Number
    1071465
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 10, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    DURING THE LAPAROSCOPY CASE, DOCTOR REMOVED THE 12MM BLUNT TIP 100MM ENDOPATH XCEL TROCAR SMOOTH SLEEVE. HE NOTICED A PLASTIC ROUND SIDE TIE-DOWN PIECE HAD BROKEN OFF THE LARGER CLEAR PLASTIC PIECE. THE LOT NUMBER WAS PROBABLY E4KT2G OR E4KE5U AS PER STERILE TROCARS ARE STOCKED IN OUR HALL BIN. THE SMALL MISSING PIECE WAS NOT NOTICED IN THE PATIENT AT THE TIME, BUT IT IS UNKNOWN WHERE THE PIECE IS LOCATED. THE DOCTOR WAS AWARE AND STATED, "THE PIECE BROKE OFF ON THE OTHER SIDE (WHEN IT WAS REMOVED WHILE TESTED ON THE OR BACK TABLE) AND WAS NOT IN THE PATIENT." A NEW TROCAR OF THE SAME TYPE NEEDED TO BE OPENED FOR THE PATIENT. WHEN A NEW TROCAR WAS CHECKED THE TWO PHLANGES ON THE ROUND PIECES HAD HOOKED ENDS AND WERE LONGER. THE TROCAR AND SUPPORTING PIECES OF PLASTIC WERE PUT IN A BIOHAZARD BAG AND SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH EXCEL TROCAR GCJ ETHICON ENDO-SURGERY, INC. H121LP E4KT2G

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR NONE KNOWN.| NONE KNOWN.