BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTF01, 5X150 KII FIOS ZTHR 6/BX

    MDR report key: 6070319 · Received November 1, 2016

    Report

    Report Number
    2027111-2016-00744
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    October 4, 2016
    Report Date
    December 28, 2016
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915124014
    PMA / PMN Number
    K041795
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION ALONG WITH THE BROKEN OBTURATOR TIP AND CLEAR FRAGMENTS. ENGINEERING CONFIRMED THE CUSTOMER'S EXPERIENCE OF THE OBTURATOR TIP BREAKING OFF. ENGINEERING REASSEMBLED THE CLEAR FRAGMENTS WITH THE OBTURATOR AND OBTURATOR TIP AND NOTED THAT THERE WERE NO MISSING PIECES. DURING THE MANUFACTURING PROCESS, ALL TROCARS ARE THOROUGHLY INSPECTED FOR FUNCTIONALITY AND PERFORMANCE PRIOR TO PACKAGING. THE ROOT CAUSE OF THE EVENT IS LIKELY DUE TO USER ERROR. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), "KII ACCESS SYSTEM CANNULAS CAN ONLY BE USED WITH THE CORRESPONDING KII OBTURATORS (DIAMETER AND LENGTH) FROM APPLIED MEDICAL." APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS. IN ACCORDANCE WITH 21 CFR 803.56, IF ADDITIONAL INFORMATION IS OBTAINED 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

    THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED 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. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    LAPAROSCOPIC CHOLECYSTECTOMY - "DURING RE-INSERTION (PORT HAD PREVIOUSLY SLIPPED OUT) OF THE 5MM TROCAR INTO THE PATIENT, THE SHAFT OF THE TROCAR CANNULA AND OBTURATOR BEGAN TO BEND. THE TROCAR WAS THEN REPLACED FOR ANOTHER CTF01. HOWEVER, MISTAKENLY THE SURGEON PLACED THE CTF01 OBTURATOR THROUGH A CTF12 CANNULA. WHEN INSERTING THIS TROCAR THROUGH THE EXISTING DEFECT THE TIP OF THE OBTURATOR SNAPPED OFF AND REMAINED BETWEEN THE ABDOMINAL LAYERS. THE OBTURATOR TIP (ALONG WITH SEVERAL PIECES) WERE RETRIEVED FROM THE PATIENT. IN THE SAME CASE 1X CTF73' & 2X CTS22'S WERE NOT ALLOWING GAS TO BE EXPELLED THROUGH THE INSUFFLATION PORT OF THE TROCAR IN ORDER TO DESUFFLATE THE PATIENT. THE STAFF COULD NOT BE SURE WHETHER THE FAULT WAS WITH THE TROCAR, INSUFFLATION SYSTEM OR TO DO WITH PATIENT POSITIONING (AS THE PATIENT WAS HIGH BMI). THE HOSPITAL ARE NOW IN PROCESS OF TESTING THEIR INSUFFLATION SYSTEM." PATIENT STATUS: "NO PATIENT INJURY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721804 CTF01, 5X150 KII FIOS ZTHR 6/BX GCJ GCJ APPLIED MEDICAL RESOURCES CTF01 1247406 00607915124014

    Patients

    Seq Age Sex Outcome Treatment
    1