BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS VISERA CYSTO-NEPHRO ENDOSCOPE

    MDR report key: 2187537 · Received July 22, 2011

    Report

    Report Number
    8010047-2011-00167
    Event Type
    Other
    Date Received
    July 22, 2011
    Date of Event
    May 14, 2011
    Report Date
    June 24, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE SUBJECT DEVICE UNDERWENT CULTURING AND THE RESULT WAS (B)(6) FOR PSEUDOMONAS AERUGINOSA. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND SLIGHT BROWNISH RESIDUE IN THE SUCTION CYLINDER AND IN THE DISTAL END OF THE INSTRUMENT CHANNEL. IN ADDITION, THE USER FACILITY WAS DETERMINED NOT TO BE REPROCESSING THE ENDOSCOPES IN ACCORDANCE WITH THE DIRECTIONS FOR USE, AND WERE STORING THE DEVICE IN A MANNER THAT DID NOT PROMOTE DRYING BETWEEN USES. AS PART OF THE F/U TO THIS REPORT, THE USER FACILITY WAS PROVIDED TRAINING ON HOW TO APPROPRIATELY REPROCESS THE ENDOSCOPE. PLEASE ALSO REFERENCE MFG REPORT # 8010047-2011-00166 FOR A RELATED REPORT. 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 TWO PTS HAD TESTED (B)(6) FOR PSEUDOMONAS AERUGINOSA AFTER UNDERGOING A CYSTOSCOPY USING THE SUBJECT DEVICE. ONE OF TWO PTS REPORTEDLY EXPERIENCED PAIN DURING URINATION AND WAS PROVIDED WITH ANTIBIOTIC. THERE WERE NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VISERA CYSTO-NEPHRO ENDOSCOPE CYSTOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORP. CYF-VA2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1