BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII FIOS FIRST ENTRY

    MDR report key: 5027346 · Received August 25, 2015

    Report

    Report Number
    5027346
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Date of Event
    December 16, 2014
    Report Date
    August 3, 2015
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USING THE 12MM FIOS OPTIVIEW, THE ABDOMEN WAS ENTERED UNDER DIRECT VISION AND PNEUMOPERITONEUM WAS ESTABLISHED AT 15MMHG. THE ZERO DEGREE LAPAROSCOPE WAS THEN SWITCHED OUT FOR A 30 DEGREE SCOPE. AS THE SURGEON WAS INSERTING THE KII FIOS FIRST ENTRY 5X100MM DEVICE (REF:CTF03, LOT 1231828) INTO THE PATIENT, THE TROCAR (INNER SHEATH) BROKE IN TWO. BOTH PIECES WERE RETRIEVED AND ANOTHER FIRST ENTRY DEVICE WAS OPENED TO THE FIELD AND USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561341 KII FIOS FIRST ENTRY TROCAR GCJ APPLIED MEDICAL RESOURCES CORP 1231828

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR NO OTHER DEVICES CONTRIBUTED TO THE EVENT THAT WE