BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS TRACHEAL INTUBATION FIBERSCOPE

    MDR report key: 2040197 · Received March 24, 2011

    Report

    Report Number
    8010047-2011-00058
    Event Type
    Other
    Date Received
    March 24, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE USERS WERE REPORTEDLY FLUSHING THE SUCTION CHANNEL WITH SOAP DURING MANUAL REPROCESSING, ALONG WITH A COMBINATION OF WIPING, SOAKING THE DEVICE IN A LIQUID CHEMICAL DISINFECTANT (CIDEX OPA), AND RINSING. AN OLYMPUS ENDOSCOPE SUPPORT SPECIALIST HAS PROVIDED IN-SERVICE TRAINING TO USERS AT THIS FACILITY AND REVIEWED APPROPRIATE REPROCESSING OF THIS DEVICE. IF ADDITIONAL AND SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER TIME, THEN THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED BY THE USER FACILITY THAT THE SUCTION CHANNEL OF THE TRACHEAL INTUBATION FIBERSCOPE WAS NOT BEING BRUSHED AS PART OF THE REPROCESSING FOR THIS DEVICE. THERE WERE NO REPORTS OF ANY PT INFECTIONS OR OTHER ADVERSE IMPACTS TO PTS AS A RESULT OF THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS TRACHEAL INTUBATION FIBERSCOPE FIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEM CORPORATION LF-GP NA

    Patients

    Seq Age Sex Outcome Treatment
    1