BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJINON

    MDR report key: 5435663 · Received February 12, 2016

    Report

    Report Number
    2431293-2016-00011
    Event Type
    Injury
    Date Received
    February 12, 2016
    Date of Event
    August 4, 2012
    Report Date
    September 17, 2012
    Manufacturer
    FUJIFILM OPTICS CO., LTD. MITO FACTORY
    Product Code
    FDT
    PMA / PMN Number
    K042076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RELATED TO 2431293-2016-00012. AFTER BECOMING AWARE OF THE EVENT, FUJIFILM MEDICAL SYSTEMS (B)(4) CONDUCTED AN ON-SITE REVIEW AND OBSERVED A FAILURE TO PROPERLY FOLLOW THE CLEANING/DISINFECTION PROCEDURE, INCLUDING WHAT MAY HAVE BEEN INCORRECT CONNECTIONS TO AN OLYMPUS ETD3 REPROCESSING MACHINE. FUJIFILM MEDICAL SYSTEMS (B)(4) CONDUCTED RE-TRAINING SESSIONS FOR (B)(6) STAFF ON HOW TO REPROCESS DUODENOSCOPES. (B)(6) REPORTED ONE INFECTION (BACTEREMIA) AND ONE CASE OF BILIARY COLONIZATION WITH THE SAME GERM (PYO MULTIR) AFTER ONE DUODENOSCOPY WITH THE SAME DEVICE ON WHICH THE SAME GERM IS FOUND, AND ENTEROBACTER CLOACAE ESBL FOUND DURING THE INSPECTION AND IN THE BILIARY DRAINAGE IN THE SECOND CASE. FUJIFILM DID NOT RECEIVE ANY ADDITIONAL INFORMATION REGARDING THE TWO PATIENTS. FUJIFILM IS NOT AWARE OF ANY EVIDENCE REGARDING WHETHER THE PATIENT(S) TRANSFERRED THE GERM TO THE DUODENOSCOPE OR VICE VERSA. ALL OF THE CHANNELS AND VALVES OF THE DUODENOSCOPE WERE REPLACED AND THERE WERE NO FURTHER SIMILAR INCIDENTS. ANY CONTAMINATION WAS PROBABLY A RESULT OF NON-COMPLIANCE WITH THE CLEANING/DISINFECTION PROCEDURE. THE INCIDENT WAS, AT THE TIME, REPORTED TO THE (B)(6). FUJIFILM COOPERATED WITH (B)(6) REVIEW OF THE MATTER. THE ED-450XT8/B DUODENOSCOPE IS NOT MARKETED IN THE UNITED STATES. ACCORDINGLY, THIS MDR IS BEING FILED IN AN ABUNDANCE OF CAUTION TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

    Description of Event or Problem · 1

    FUJIFILM MEDICAL SYSTEMS (B)(4) WAS CONTACTED BY (B)(6), CONCERNING AN ED-450-XT8/B DUODENOSCOPE AND TWO PATIENT INFECTIONS. THE INCIDENT WAS REPORTED TO THE (B)(6) ON (B)(6) 2012. THE EVENT IS REGISTERED UNDER THE ANSM CASE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91303 FUJINON DUODENOSCOPE FDT FUJIFILM OPTICS CO., LTD. MITO FACTORY ED-450XT8/B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other