BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OES BRONCHOFIBERSCOPE

    MDR report key: 11735446 · Received April 27, 2021

    Report

    Report Number
    8010047-2021-05522
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Report Date
    April 28, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    ON APRIL 7, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED ""MICROBIOLOGICAL MONITORING OF FLEXIBLE BRONCHOSCOPES AFTER HIGH-LEVEL DISINFECTION AND FLUSHING CHANNELS WITH ALCOHOL: RESULTS AND COSTS. IN THE LITERATURE, IT WAS REPORTED THAT THE RESULT OF THE MICROBIOLOGICAL TEST MIGHT BE USING OLYMPUS ENDOSCOPES IN 19 OF 620 SAMPLES. AS A RESULT OF THE MICROBIOLOGICAL TESTING, THE FOLLOWING MICROBES WERE DETECTED. 18 SCOPES: BF-1T30, 3 OF BF-P40, 3 OF BF-P160, BF-UC180F, 3 OF BF-1T180, BF-XP160F, LF-TP, 4 OF LF-V, AND AN ENDOSCOPE OF COMPETITOR. SAMPLES: 620 SAMPLES. MICROBIOLOGIC RESULTS: A TOTAL OF 19 SAMPLES (4 SAMPLES OF STREPTOCOCCUS VIRIDANS, 2 SAMPLES OF ENTEROCOCCUS FAECIUM, 2 SAMPLES OF CANDIDA ALBICANS, STAPHYLOCOCCUS AUREUS, ENTEROBACTER AGGLOMERANS, 4 SAMPLES OF ASPERGILLUS FUMIGATUS, 3 SAMPLES OF PSEUDOMONAS AERUGINOSA, SERRATIA MARCESCENS, ASPERGILLUS NIGER). THERE WAS NO OTHER INFORMATION ABOUT THE INFECTION IN THIS LITERATURE. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE MICROBIOLOGICAL TESTING WAS NOT PROVIDED. THEREFORE, OMSC WILL SUBMIT 19 MEDICAL DEVICE REPORTS (MDR) DEPENDING ON THE NUMBER OF MICROBIOLOGICAL TESTING. THIS REPORT IS 17 OF 19 REPORTS ABOUT MICROBIOLOGICAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630081 OES BRONCHOFIBERSCOPE BRONCHOFIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T30

    Patients

    Seq Age Sex Outcome Treatment
    1