BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS BRONCHOSCOPE

    MDR report key: 5213992 · Received November 5, 2015

    Report

    Report Number
    MW5057769
    Event Type
    Malfunction
    Date Received
    November 5, 2015
    Date of Event
    October 15, 2015
    Report Date
    November 5, 2015
    Manufacturer
    OLYMPUS
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    INFREQUENTLY IDENTIFIED ORGANISM ISOLATED ON 2 ICU PATIENTS. INITIAL INVESTIGATION REPORTS PATIENTS UNDERWENT BRONCHOSCOPY WITH OLYMPUS SCOPE BFQ 180, SERIAL NUMBER (B)(4), HIGH LEVEL DISINFECTION USED BETWEEN USES. SURVEILLANCE AND MICROBIOLOGY TESTING IN PROGRESS. OLYMPUS MANUFACTURER NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736952 OLYMPUS BRONCHOSCOPE OLYMPUS BRONCHOSCOPE EOQ OLYMPUS BFQ 180

    Patients

    Seq Age Sex Outcome Treatment
    1 Other