BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS OES CYSTONEPHROFIBERSCOPE

    MDR report key: 1853285 · Received September 29, 2010

    Report

    Report Number
    8010047-2010-00186
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 11, 2016
    Report Date
    March 4, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCQ
    PMA / PMN Number
    K993041
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION, THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE DEVICE EVALUATION RESULTS FOR THE FOLLOWING DEVICES: CYF-5 WITH SERIAL # (B)(4), CYF-5 WITH SERIAL # (B)(4), AND CYF-5 WITH SERIAL # (B)(4). DEVICE INFO WILL BE UPDATED TO UNKNOWN AS WE DO NOT KNOW WHICH DEVICE WAS USED ON EACH PATIENT. CYF-5 WITH SN # (B)(4): THE DEVICE WAS FORWARDED TO A LABORATORY FOR MICROBIOLOGICAL TESTING. THE DEVICE TESTED NEGATIVE FOR GROWTH. THE DEVICE WAS FORWARDED TO OLYMPUS FOR EVALUATION FOLLOWING THE LABORATORY MICROBIOLOGICAL TESTING. THE EVALUATION FOUND REDDISH-ORANGE RESIDUE INSIDE THE DEVICE. THE EVALUATION ALSO FOUND THAT THE DEVICE FAILED LEAK TESTING AT THE CONTROL BODY. CYF-5 WITH SN # (B)(4): THE DEVICE WAS FORWARDED TO A LABORATORY FOR MICROBIOLOGICAL TESTING. THE DEVICE TESTED NEGATIVE FOR GROWTH. THE DEVICE WAS FORWARDED TO OLYMPUS FOR EVALUATION FOLLOWING THE LABORATORY MICROBIOLOGICAL TESTING. THE EVALUATION FOUND WHITE RESIDUE IN THE INSTRUMENT CHANNEL PORT AND ON THE DISTAL END OF THE DEVICE. THE EVALUATION ALSO FOUND DEEP CUTS IN THE INSERTION TUBE. CYF-5 WITH SN # (B)(4): THE DEVICE WAS FORWARDED TO A LABORATORY FOR MICROBIOLOGICAL TESTING. THE DEVICE TESTED NEGATIVE FOR GROWTH. THE DEVICE WAS FORWARDED TO OLYMPUS FOR EVALUATION FOLLOWING THE LABORATORY MICROBIOLOGICAL TESTING. THE EVALUATION FOUND WHITE RESIDUE IN THE INSTRUMENT CHANNEL PORT AND ON THE DISTAL END OF THE DEVICE. THE EVALUATION ALSO FOUND 8 BROKEN IMAGE FIBERS AND A LEAK AT THE ETO VALVE. BASED ON THE DEVICE EVALUATION RESULTS, THE MOST LIKELY CAUSE OF THE REPORTED EVENTS IS DUE TO IMPROPER MAINTENANCE OF THE DEVICE. PLEASE CROSS REFERENCE MFR. REPORT NUMBERS: 8010047-2010-00184, 8010047-2010-00185, 8010047-2010-00190, 2951238-2016-00155, 2951238-2016-00156, 2951238-2016-00157, 2951238-2016-00158, 2951238-2016-00159, AND 2951238-2016-00160 TO ACCOUNT FOR THE TEN PATIENTS AS REFERENCED IN THE ORIGINAL REPORT.

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA PHONE AND IN WRITING TO GATHER MORE INFORMATION FOR THIS REPORT. THE FIRST INFECTION WAS SAID TO HAVE BEEN IDENTIFIED ON (B)(6)2010, BUT NO ADDITIONAL INFORMATION REGARDING THE STATUS OF THE PATIENTS OR THE ALLEGED INFECTIONS WAS PROVIDED. THE SUBJECT DEVICE OF THIS REPORT WAS FORWARDED TO AN INDEPENDENT MICROBIOLOGICAL TESTING LABORATORY FOR CULTURING FOLLOWED BY ETHYLENE OXIDE STERILIZATION. OLYMPUS HAS BEEN INFORMED THAT THE SCOPE TESTED NEGATIVE FOR GROWTH. FOLLOWING STERILIZATION, THE DEVICE WAS FORWARDED TO OLYMPUS FOR EVALUATION. THE INSTRUMENT CHANNEL WAS EXAMINED, AND WHITE RESIDUE WAS FOUND INSIDE THE INSTRUMENT CHANNEL PORT AND THE DISTAL END OF THE INSTRUMENT CHANNEL. THE EVALUATION ALSO FOUND A LEAK AT THE AIR VALVE. AT THE PRESENT TIME, THE EXACT CAUSE OF THE REPORTED PHENOMENON CANNOT BE DETERMINED, HOWEVER, INSUFFICIENT REPROCESSING AND USER HANDLING CANNOT BE RULED OUT AS CONTRIBUTORY FACTORS. THE DEVICE IS AWAITING APPROVAL FROM THE USER FACILITY FOR SERVICE TO BE PERFORMED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS IS REPORT TWO OF FOUR. PLEASE SEE ALSO MFR#S: 8010047-2010-00190, 8010047-2010-00184 AND 8010047-2010-00185. (B)(4)

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A REPORT FROM THE USER FACILITY THAT ALLEGED THERE WERE A TOTAL OF SEVEN PATIENTS THAT HAD DEVELOPED URINARY E. COLI INFECTIONS, AND IT WAS NOT KNOWN WHICH OF FOUR DEVICES HAD BEEN ALLEGED TO BE THE SOURCE OF THE INFECTIONS. THE SUBJECT DEVICE HAD REPORTEDLY BEEN CULTURED AT THE USER FACILITY, AND TESTED NEGATIVE. THERE WAS NO FURTHER INFORMATION PROVIDED REGARDING THE STATUS OF THE PATIENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other