BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTF03, 5X100 KII FIOS Z-THR 6/BX

    MDR report key: 5106198 · Received September 25, 2015

    Report

    Report Number
    2027111-2015-00684
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    December 16, 2014
    Report Date
    September 25, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    PMA / PMN Number
    K041795
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS TO FOLLOW UP WITH MEDWATCH# (B)(4) AND MAUDE REPORT# 5027346 INVESTIGATION SUMMARY: THE INCIDENT PRODUCT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING CONFIRMED THAT THE OBTURATOR WAS FRACTURED INTO TWO PIECES AT THE THIRD SUPPORT PIN HOLE FROM THE DISTAL END. THE OBTURATOR WAS REASSEMBLED TO SEE IF THE SHAFT WAS FULLY INTACT. ENGINEERING MATED THE PIECES AND NOTED THAT ALL PIECES HAVE BEEN RETURNED. BASED ON THE EVALUATION OF THE RETURNED PRODUCT, THIS INCIDENT IS MOST LIKELY DUE TO A VARIATION IN THE MANUFACTURING PROCESS. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION, AND EASE OF USE OF ITS PRODUCTS. APPLIED MEDICAL HAS RECENTLY IMPLEMENTED ADDITIONAL PROCESS IMPROVEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF INCIDENT TO OCCUR. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    (B)(4). RA HAS RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAPRASCOPIC SLEEVE GASTRECTOMY AND LAPAROSCOPIC CREATION OF OMENTAL FLAP -"USING THE 12 MM 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
    636733 CTF03, 5X100 KII FIOS Z-THR 6/BX GCJ GCJ APPLIED MEDICAL CTF03 1231828

    Patients

    Seq Age Sex Outcome Treatment
    1