BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTF01, 5X150 KII FIOS ZTHR 6/BX

    MDR report key: 5804538 · Received July 19, 2016

    Report

    Report Number
    2027111-2016-00527
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    June 21, 2016
    Report Date
    May 10, 2017
    Manufacturer
    AMR
    Product Code
    GCJ
    UDI-DI
    00607915124014
    PMA / PMN Number
    K060096
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION - MODEL# CTF01, 5X150 KII FIOS ZTHR 6/BX.

    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.

    Additional Manufacturer Narrative · 1

    THE EVENT PRODUCT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. UPON INSPECTION, ENGINEERING CONFIRMED THE COMPLAINANT'S EXPERIENCE OF A FRACTURED CANNULA. THE LIKELY ROOT CAUSE OF THE FRACTURED CANNULA IS DUE TO MATERIAL DEGRADATION DURING THE MOLDING PROCESS, WHICH COULD CAUSE THE PART TO BE MORE PRONE TO BRITTLE FRACTURES. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE MODE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION AND EASE OF USE OF ITS PRODUCTS. AS PART OF THIS PROCESS, APPLIED MEDICAL IS CURRENTLY RESEARCHING POSSIBLE PROCESS ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF EVENT TO OCCUR.

    Description of Event or Problem · 1

    LAP CHOLE - "END OF CASE WHEN THE DOCTOR WAS PULLING OUT THE TROCAR, SHE PULLED IT OUT AND NOTICED THAT THE CANNULA WAS BROKEN. THE REST OF IT WAS JUTTING OUT OF THE PATIENT. SHE TOOK A HEMOSTAT AND PULLED THE REST OF THE CANNULA OUT. ONE PIECE HAD COMPLETELY SEPARATED FROM THE OTHER. CLEAN BREAK, NOTHING FELL INTO THE PATIENT. COMMENT FROM REP: "LARGER PATIENT PROBABLY A LOT OF TORQUING." PATIENT STATUS- NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460153 CTF01, 5X150 KII FIOS ZTHR 6/BX GCJ GCJ AMR CTF01 1233191 00607915124014

    Patients

    Seq Age Sex Outcome Treatment
    1