BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 1520492 · Received October 28, 2009

    Report

    Report Number
    8010047-2009-00211
    Event Type
    Other
    Date Received
    October 28, 2009
    Report Date
    September 29, 2009
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) PROVIDED IN-SERVICE TRAINING AT THE USER FACILITY TO REVIEW THE APPROPRIATE REPROCESSING OF ENDOSCOPE. BASED ON THE INFO PROVIDED, THE USER FACILITY STAFF DID NOT REPROCESS THE DEVICE IN ACCORDANCE WITH THE DIRECTIONS FOR USE. IF SIGNIFICANT ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 USER FACILITY HAD NOT BEEN REPROCESSING THE ELEVATOR WIRE CHANNEL ON THE SUBJECT DEVICE FOR A PERIOD OF APPROX SIX MONTHS. THERE WERE NO REPORTS OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE DUODENOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORPORATION TJF-160F NA

    Patients

    Seq Age Sex Outcome Treatment
    1