BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CFF33, 11X100 KII FIOS ADVFIX 6/BX

    MDR report key: 5998769 · Received October 4, 2016

    Report

    Report Number
    2027111-2016-00674
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Report Date
    December 5, 2016
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    K083638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT # HAS BEEN PROVIDED TO MANUFACTURER. A FOLLOW UP REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. 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 NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LAST THREE LOTS PURCHASED SHOWED THAT THE PRODUCT MET ALL MANUFACTURING AND QUALITY STANDARDS. DURING THE MANUFACTURING PROCESS, ALL TROCARS ARE THOROUGHLY INSPECTED FOR FUNCTIONALITY AND PERFORMANCE PRIOR TO PACKAGING. THE ROOT CAUSE OF THE COMPLAINANT'S EXPERIENCE OF A BROKEN SLEEVE COULD NOT BE CONFIRMED BECAUSE THE EVENT UNIT WAS NOT RETURNED. ALTHOUGH THE ROOT CAUSE COULD NOT BE DETERMINED, IT IS POSSIBLE THAT THE CANNULA COULD HAVE BEEN EXPOSED TO EXCESSIVE FORCE. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. 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 THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    UNKNOWN PROCEDURE - "DISTAL PART OF SLEEVE BROKEN DURING SURGERY. NO ADDITIONAL INFORMATION AVAILABLE AS HOSPITAL DID NOT REPORT THE CASE AT THE TIME OF THE EVENT BUT ONLY A MONTH LATER." PATIENT STATUS - UNKNOWN. TYPE OF INTERVENTION - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648373 CFF33, 11X100 KII FIOS ADVFIX 6/BX GCJ GCJ APPLIED MEDICAL RESOURCES CFF33 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1