BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA BRONCHOVIDEOSCOPE

    MDR report key: 2091118 · Received May 6, 2011

    Report

    Report Number
    8010047-2011-00092
    Event Type
    Other
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE PT HAD UNDERGONE A BRONCHOSCOPY PROCEDURE ON AN UNSPECIFIED DATE AND REPORTEDLY CONTRACTED THE CANDIDA YEAST INFECTION IN THE ORAL AREA. THE PT WAS DESCRIBED AS BEING AT HIGH RISK OF CONTRACTING CANDIDA AS THE PT'S MOUTH BECAME DRY DURING THE PROCEDURE. THE SUBJECT SCOPE HAD BEEN SUBSEQUENTLY ISOLATED BY THE USER FACILITY. MICROBIOLOGICAL CULTURING OF THE SCOPE BY THE USER FACILITY WAS NEGATIVE. THE DEVICE WAS ALSO SENT TO AN INDEPENDENT TESTING LAB FOR MICROBIOLOGICAL TESTING PRIOR TO BEING RETURNED TO OLYMPUS FOR EVAL. THE RESULTS OF THE TESTING ARE PENDING, AND THE DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVAL. THIS REPORT WILL BE SUPPLEMENTED WHEN THE EVAL IS COMPLETE. AS PART OF OUR INVESTIGATION INTO THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS BEEN DISPATCHED TO THE USER FACILITY TO ASSESS THE FACILITY'S REPROCESSING PRACTICES AND PROVIDE REPROCESSING TRAINING IF NECESSARY. THE EXACT CAUSE OF THE PT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. IF ADD'L AND SIGNIFICANT INFO IS RECEIVED AT A LATER DATE, THIS REPORT WILL BE UPDATED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. THIS IS ONE OF THE TWO REPORTS, CROSS-REFERENCE MFR REPORT#: 8010047-2011-00093.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PT REPORTEDLY CONTRACTED A CANDIDA YEAST INFECTION AFTER HAVING UNDERGONE A BRONCHOSCOPY PROCEDURE. THE USER FACILITY REPORTEDLY PERFORMED CULTURES ON THE SUBJECT DEVICE AND THE DEVICE TESTED NEGATIVE. THE USER FACILITY PROVIDED NO INFO REGARDING THE STATUS OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA BRONCHOVIDEOSCOPE BRONCHOSCOPE EOQ OLYMPUS MEDICAL SYSTEM CORPORATION BF-160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1