BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS OES CYSTONEPHROFIBERSCOPE

    MDR report key: 2913606 · Received January 7, 2013

    Report

    Report Number
    8010047-2013-00004
    Event Type
    Other
    Date Received
    January 7, 2013
    Report Date
    December 10, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCE WAS NOT RETURNED TO OLYMPUS FOR EVAL. THE USERS WERE REPORTEDLY HIGH LEVEL DISINFECTING THE ENDOSCOPES BY SOAKING THE ENDOSCOPES MANUALLY. AN OLYMPUS ENDOSCOPE SUPPORT SPECIALIST HAS PROVIDED IN-SERVICE TRAINING TO USERS AT THIS FACILITY AND REVIEWED APPROPRIATE REPROCESSING OF THIS DEVICE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED DURING AN IN-SERVICE THAT THE USER FACILITY WAS OMITTING ALL OF THE PRE-CLEANING STEPS, NOT LEAK TESTING ALL OF THE TIME, NOT USING ENZYMATIC CLEANING SOLUTION, NOT PROPERLY STORING THE ENDOSCOPES, AND WAS NOT BRUSHING OF THE SCOPE CHANNEL DURING REPROCESSING. THERE WERE NO REPORTS OF ANY PT INFECTIONS OR OTHER ADVERSE IMPACTS TO PTS AS A RESULT OF THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8316 OLYMPUS OES CYSTONEPHROFIBERSCOPE CYSTOSCOPE GCQ OLYMPUS MEDICAL SYSTEMS CORPORATION CYF-5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1