BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERAII BRONCHOVIDEOSCOPE

    MDR report key: 8538976 · Received April 23, 2019

    Report

    Report Number
    8010047-2019-01785
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    March 12, 2019
    Report Date
    April 23, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS (B)(4). (B)(4) SENT THE SUBJECT DEVICE TO A THIRD PARTY LABORATORY FOR AN ADDITIONAL MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, NO MICROBE WAS DETECTED FROM THE SAMPLE COLLECTED FROM ALL CHANNELS OF THE SUBJECT DEVICE. THE TESTING RESULT CLEARED THE (B)(6) GUIDELINE. 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 MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE TESTED POSITIVE FOR AUTRES (1 CFU/100ML). THE DEVICE HAD BEEN REPROCESSED USING A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL SOLUSCOPE S4 (SOLUSCOPE) WITH PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335778 EVIS EXERAII BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-Q180

    Patients

    Seq Age Sex Outcome Treatment
    1