BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS CYSTOVIDEOSCOPE

    MDR report key: 1379382 · Received May 4, 2009

    Report

    Report Number
    8010047-2009-00083
    Event Type
    Other
    Date Received
    May 4, 2009
    Date of Event
    April 1, 2009
    Report Date
    April 6, 2009
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FAJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE DEVICE PASSED ELECTRICAL LEAKAGE TESTING, HOWEVER THE DISTAL END COVER WAS NOTED TO BE LOOSE. A SMALL BUMP WAS NOTED ON THE BENDING SECTION COVER 5 MM FROM THE DISTAL END. ADDITIONALLY, THERE WERE MINOR SCRAPE MARKS NOTED ON THE BENDING SECTION CEMENT WITH AREAS OF DAMAGE TO THE BENDING SECTION COVER GLUE. THERE WERE ALSO CRACKS FOUND IN THE LIGHT SOURCE CONNECTOR BODY, WHICH WERE DETERMINED TO BE DUE TO PHYSICAL DAMAGE. THE CAUSE OF THE USER'S EXPERIENCE COULD NOT CONCLUSIVELY BE DETERMINED. THE DEVICE HAS BEEN FORWARDED TO THE ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER ANALYSIS. IF ADDITIONAL SIGNIFICANT INFORMATION IS OBTAINED, THIS REPORT WILL BE UPDATE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT UPON INSERTING THE CYSTOSCOPE INTO THE PT'S URETHRA, THE PT REPORTED FEELING A TINGLING SENSATION RADIATING FROM HIS PENIS INTO HIS LEG. THE DEVICE WAS IMMEDIATELY WITHDRAWN, AND A DIFFERENT, BUT SIMILAR DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PT INJURY REPORTED, AND THE PT WAS DISCHARGED FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS CYSTOVIDEOSCOPE CYSTOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORPORATION CYF-V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other