BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTF73, 12X100 KII FIOS ZTHR 6/BX

    MDR report key: 5784337 · Received July 11, 2016

    Report

    Report Number
    2027111-2016-00506
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 14, 2016
    Report Date
    May 10, 2017
    Manufacturer
    AMR
    Product Code
    GCJ
    UDI-DI
    00607915123703
    PMA / PMN Number
    K041795
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    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 INCIDENT TO OCCUR.

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE 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

    ROBOTIC PROSTATECTOMY, LEFT NERVE SPARING, PELVIC LYMPH NODE DISSECTION - "TROCAR WAS BEING USED FOR THE CAMERA PORT. HALF WAY THROUGH PROCEDURE THE SURGEON COULD NOT KEEP INSUFFLATION. ALL OTHER PORTS WERE CHECKED. WHEN CAMERA PORT WAS REMOVED AFTER CASE IT WAS FOUND TO HAVE CRACKED AND THEREFORE THE CAUSE OF THE LACK OF INSUFFLATION." ADDITIONAL INFORMATION RECEIVED: 6/21/2016 "THE CANNULA CRACKED ALONG THE SHAFT . WE WERE NOT SURE WHEN EXACTLY DURING THE PROCEDURE IT CRACKED, JUST THAT AS THE PROCEDURE PROGRESSED HOLDING INSUFFLATION BECAME INCREASINGLY MORE DIFFICULT. THE CANNULA STAYED INTACT SO THERE WERE NO PARTICLES THAT NEEDED TO BE RETRIEVED. ONCE I HAVE THE RGA NUMBER I WILL HAVE THE CLIENT RETURN THE ACTUAL TROCAR SO YOU CAN SEE WHERE ON THE SHAFT THE TROCAR CRACKED ." TYPE OF INTERVENTION - "N/A". PATIENT STATUS - "PROCEDURE TOOK MUCH LONGER AND NOT ALL NODES WERE CHECKED. INCIDENT REPORT WRITTEN UP BY HOSPITAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437734 CTF73, 12X100 KII FIOS ZTHR 6/BX GCJ GCJ AMR CTF73 1267073 00607915123703

    Patients

    Seq Age Sex Outcome Treatment
    1