BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERSCOPE "CYF-5", EUROPEAN VERSION

    MDR report key: 8806301 · Received July 19, 2019

    Report

    Report Number
    8010047-2019-02603
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Report Date
    July 19, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    PMA / PMN Number
    K032092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAD NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC). BUT WAS RETURNED TO OLYMPUS (B)(4). THE SUBJECT DEVICE WAS SENT TO A THIRD-PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. IN THE ADDITIONAL TEST, THE TESTING INDICATED NO MICROBIAL GROWTH FOR THE SUBJECT DEVICE. THE PHYSICAL FINDINGS OF THE SUBJECT DEVICE WERE NOT REPORTED. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SUBJECT DEVICE REPEATEDLY TESTED POSITIVE FOR THE FOLLOWING BACTERIA: ON (B)(6) 2019: THE BIOPSY CHANNEL: UNSPECIFIED BACTERIA (9 CFU/100ML). THE SUBJECT DEVICE HAD BEEN BRUSHED MANUALLY USING A NON-OLYMPUS CLEANING BRUSH(PRINCE MEDICAL, KIT 1 CLEAN: DIAMETRE 1.8) AND DISINFECTED USING NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR (GETINGE, POKA-YOKE) WITH PERACETIC ACID. THERE WAS NO REPORT OF PATIENT INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600323 FIBERSCOPE "CYF-5", EUROPEAN VERSION CYSTONEPHROFIBERSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORP. CYF-5

    Patients

    Seq Age Sex Outcome Treatment
    1