BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS OES CYSTONEPHROFIBERSCOPE

    MDR report key: 2974799 · Received February 15, 2013

    Report

    Report Number
    8010047-2013-00064
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    March 3, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GCQ
    PMA / PMN Number
    K993041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT. THE USER FACILITY REPORTED THAT THE FOUR PATIENTS WERE CULTURED AND THE RESULTS WERE POSITIVE FOR THE SAME MICROORGANISM. THE USER FACILITY CLAIMED THAT THE REPROCESSING AREA INCLUDING THE BASIN WERE CULTURED WITH NO GROWTH FOUND. THE DEVICE WAS SENT TO AN INDEPENDENT TESTING LABORATORY FOR MICROBIOLOGICAL TESTING. THE RESULTS OF THE TESTING ARE PENDING, AND THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THIS REPORT WILL BE SUPPLEMENTED WHEN THE EVALUATION IS COMPLETE. AS PART OF OUR INVESTIGATION INTO THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST WAS DISPATCHED TO THE USER FACILITY TO ASSESS THE FACILITY'S REPROCESSING PRACTICES AND PROVIDE REPROCESSING TRAINING IF NECESSARY. HOWEVER, THE USER FACILITY HAD DECLINED THE IN-SERVICE. THE EXACT CAUSE OF THE PATIENTS' OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED, BUT INSUFFICIENT REPROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR. THE REFERENCED DEVICE WAS RETURNED TO OLYMPUS FOR SERVICE/REPAIR ON (B)(4) 2012 AND A NEW BENDING SECTION COVER WAS INSTALLED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT FOUR PATIENTS THAT HAVE HAD UNDERGONE CYSTOSCOPY PROCEDURES USING THE REFERENCED DEVICE HAD DEVELOPED PSEUDOMONAS UTI, SEPSIS WITH THE SAME RESISTANT BACTERIA AND RESISTANCE PROFILE. THE USER FACILITY REPORTED THAT STERILIZATION PROCESS WAS ASSESSED BY AN UNIDENTIFIED OLYMPUS NURSE SPECIALIST WITH NO ISSUES OBSERVED. THE USER FACILITY CLAIMED THAT THERE WAS A "NIDUS" OF BACTERIA WITHIN THE CHANGED SHEATH AS THE DEVICE WAS RETURNED PREVIOUSLY FOR A BUCKLING SHEATH ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69684 OLYMPUS OES CYSTONEPHROFIBERSCOPE CYSTOSCOPE GCQ OLYMPUS MEDICAL SYSTEM CORPORATION CYF-5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention