BEUDAMED
    FDA Adverse Event Summary report: N

    FUJINON

    MDR report key: 4101493 · Received August 27, 2014

    Report

    Report Number
    2431293-2014-00004
    Date Received
    August 27, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 27, 2014
    Manufacturer
    FUJIFILM OPTICS CO., LTD. MITO FACTORY
    Product Code
    FDA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FUJIFILM CLINICAL SALES SPECIALIST ADVISED THE CUSTOMER TO CONTACT (B)(4)S (THE AER MANUFACTURER) DIRECTLY TO OBTAIN CORRECT CONNECTOR KITS AND INSTRUCTIONS REGARDING REPROCESSING OF FUJIFILM ENDOSCOPES. TO DATE, THE FACILITY CONTINUES TO PERFORM PROCEDURES. NO PATIENT INCIDENCES HAVE BEEN REPORTED. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    BETWEEN (B)(4) 2014, A FUJIFILM CLINICAL SALES SPECIALIST (CSS) OBSERVED THAT CERTAIN FUJIFILM ENDOSCOPES WERE NOT BEING REPROCESSED CONSISTENT WITH FUJIFILM INSTRUCTION MANUALS AND IT APPEARED THE USER FACILITY WAS NOT ADHERING TO THE AER OEM'S ((B)(4)) AUTOMATED REPROCESSING RECOMMENDATIONS, INCLUDING THE USE OF VALIDATED AER OEM-RECOMMENDED CHANNEL ADAPTERS. BASED UPON INFORMATION PROVIDED, THE (B)(4) DSD AER HOOKUP ADAPTERS AS WELL AS THE AER-TO-SCOPE CHANNEL CONNECTIONS WERE DIFFERENT FROM THOSE DESCRIBED IN CURRENT (B)(4) PRODUCT LABELING FOR THE AUTOMATED REPROCESSING OF CERTAIN FUJIFILM ENDOSCOPES. THE FUJIFILM CSS REVIEWED APPROPRIATE MANUAL REPROCESSING INSTRUCTIONS WITH THE CUSTOMER, INCLUDING CLEANING AND LEAKING TESTING PRIOR TO AUTOMATED REPROCESSING IN AN AER. SINCE FUJIFILM PERSONNEL ARE NOT CERTIFIED AS TRAINERS BY EACH AER OEM, AND COMPANY POLICY PROHIBITS IN-SERVICES OF SPECIFIC AER PRODUCTS, THE CSS RECOMMENDED THAT THE CUSTOMER CONTACT (B)(4) DIRECTLY TO OBTAIN AND FOLLOW (B)(4) DEVICE-SPECIFIC AUTOMATED REPROCESSING INSTRUCTIONS FOR THE SCOPE MODELS IN QUESTION. THIS EVENT IS A POTENTIAL PATIENT SAFETY CONCERN DUE TO USER ERROR, RESULTING FROM INADEQUATE REPROCESSING OF REUSABLE DEVICES. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522517 FUJINON FUJINON ENDOSCOPES FDA FUJIFILM OPTICS CO., LTD. MITO FACTORY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other RELATED HOOKUP ADAPTERS| (B)(4) DSD AUTOMATED ENDOSCOPE REPROCESSOR