BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 2933386 · Received December 21, 2012

    Report

    Report Number
    8010047-2012-00450
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FAJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. AT THE PRESENT TIME, THE EXACT CAUSE OF THE REPORTED PHENOMENON CANNOT BE DETERMINED, HOWEVER INSUFFICIENT MAINTENANCE AND USER HANDLING CANNOT BE RULED OUT AS CONTRIBUTORY FACTORS. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. CROSS-REFERENCE MFR. REPORT# 8010047-2012-00445, FOR OTHER RELATED REPORTS.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE BIOPSY CHANNELS OF TWO DEVICES KINKED AND LEAKED, A PATIENT MIGHT HAVE BEEN EXPOSED TO CONTAMINATED FLUID FROM THE BIOPSY CHANNEL. THE USER HAS BEEN PERFORMING SOME BLOOD WORKS ON THE PATIENT TO TEST FOR INFECTION, AND REPORTED THE CONTAMINATION RISK WAS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE CYSTOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORPORATION CYF-V2

    Patients

    Seq Age Sex Outcome Treatment
    1