BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS RHINO-LARYNGO FIBERSCOPE

    MDR report key: 3772283 · Received March 4, 2014

    Report

    Report Number
    2951238-2014-00081
    Event Type
    Other
    Date Received
    March 4, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 13, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    EOB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. A REVIEW OF THE INSTRUMENT HISTORY INDICATED THAT THE DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR SERVICE EVER SINCE THE USER FACILITY PURCHASED THE DEVICE ON (B)(4) 2000.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE USER FACILITY WAS NOT REPROCESSING THE RHINO-LARYNGO FIBERSCOPE IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THE USER FACILITY WAS NOT LEAK TESTING AND NOT PERFORMING HIGH LEVEL DISINFECTION. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS PROVIDED IN-SERVICE TRAINING TO THE FACILITY STAFF AND REVIEWED THE APPROPRIATE REPROCESSING OF THE RHINO-LARYNGO FIBERSCOPE. NO PT INFECTION OR CROSS-CONTAMINATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131064 OLYMPUS RHINO-LARYNGO FIBERSCOPE RHINO-LARYNGO FIBERSCOPE EOB OLYMPUS MEDICAL SYSTEM CORPORATION ENF-P4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other