BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA II BRONCHOVIDEOSCOPE

    MDR report key: 2141097 · Received June 15, 2011

    Report

    Report Number
    8010047-2011-00125
    Event Type
    Other
    Date Received
    June 15, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 17, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS FORWARDED TO AN INDEPENDENT MICROBIOLOGY LABORATORY FOR MICROBIOLOGICAL TESTING. TEST RESULTS FROM THIS TESTING ARE PENDING. OLYMPUS WAS INFORMED THAT THREE OF THE FIVE REPORTED INFECTIONS TOOK PLACE IN (B)(4) 2011, ANOTHER ON (B)(4) 2011, AND THE FIFTH ON (B)(4) 2011. AS PART OF THE INVESTIGATION INTO THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO ASSESS THE REPROCESSING PRACTICES BEING EMPLOYED. THE USER FACILITY STAFF WERE NOT OBSERVED TO PERFORM PRE-CLEANING, AND A FLUSHING PUMP WAS REPORTEDLY NOT MAINTAINED IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THE ESS HAS PROVIDED INFO REGARDING APPROPRIATE REPROCESSING AND MAINTENANCE OF THE BRONCHOSCOPES AND FLUSHING PUMP. A PHYSICAL EVALUATION OF THE BRONCHOSCOPE WILL FOLLOW ONCE THE DEVICE IS RECEIVED FROM THE MICROBIOLOGY LABORATORY, AND THIS REPORT WILL BE SUPPLEMENTED. THE CAUSE OF THE USER'S REPORT CANNOT BE CONCLUSIVELY DETERMINED. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION. THIS IS REPORT TWO OF FIVE REPORTS: CROSS REFERENCE MFR. NUMBER 8010047-2011-00122, 8010047-2011-00123, 8010047-2011-00124, AND 8010047-2011-00126.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT FIVE PTS HAD ACQUIRED HEMOPHILUS HAEMOLYTICUS AND/OR MYCOBACTERIUM AVIUM COMPLEX INFECTIONS AFTER HAVING UNDERGONE A BRONCHOSCOPY WITH THE SUBJECT DEVICE. THE EXAMINATIONS WERE SAID TO HAVE OCCURRED BETWEEN (B)(6) 2011. ALL PTS WERE OUTPATIENTS. THE STAFF AT THE USER FACILITY FURTHER REPORTED THAT THEY DO NOT SUSPECT THE BRONCHOSCOPE TO BE THE CAUSE OF THE PTS' INFECTIONS. THERE WAS NO FURTHER INFO PROVIDED ON THE STATUS OF THE PT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II BRONCHOVIDEOSCOPE BRONCHOSCOPE EOQ OLYMPUS MEDICAL SYSTEM CORPORATION BF-Q180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1