BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS BRONCHOFIBERSCOPE

    MDR report key: 2181539 · Received July 15, 2011

    Report

    Report Number
    8010047-2011-00155
    Event Type
    Other
    Date Received
    July 15, 2011
    Report Date
    June 16, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION. AN OLYMPUS REPRESENTATIVE VISITED THE USER FACILITY ON (B)(4), 2011, TO ASSESS THE USER FACILITY'S REPROCESSING PRACTICES. THE OLYMPUS REPRESENTATIVE REPORTED THE DEVICE WAS NOT BEING REPROCESSED IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THE USER FACILITY DID NOT HAVE A STANDARDIZED REPROCESSING METHOD FOR THE DEVICE, AND THERE WAS VARIATION IN REPROCESSING AMONG STAFF. ADDITIONALLY, THE USER FACILITY WAS REPORTEDLY USING A LOW-LEVEL DISINFECTANT TO REPROCESS THE BRONCHOSCOPE. THE OLYMPUS REPRESENTATIVE HAS PROVIDED TRAINING REGARDING APPROPRIATE REPROCESSING TO THE USER FACILITY PERSONNEL. THERE WAS NO FURTHER INFO OBTAINED REGARDING THE PTS INVOLVED INTO THIS REPORT. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BUT INSUFFICIENT REPROCESSING OF THE DEVICE COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE SUBJECT DEVICE HAS NOT BEEN REPROCESSED IN A HIGH-LEVEL DISINFECTANT. A TOTAL OF 31 PTS WERE SAID TO HAVE BEEN AFFECTED. ONE OF THE 31 PTS WAS SAID TO HAVE BEEN TESTED POSITIVE FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS BRONCHOFIBERSCOPE BRONCHOSCOPE EOQ OLYMPUS MEDICAL SYSTEM CORPORATION BF-3C30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1