BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 3161874 · Received June 7, 2013

    Report

    Report Number
    8010047-2013-00175
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    October 19, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY RETURNED ON TJF-Q180V WITH SERIAL NUMBER 2101850 ALONG WITH TWO TJF-160VFS WITH SERIAL NUMBERS: (B)(4) TO OLYMPUS FOR EVALUATION. THE TWO TJF-160VFS WAS RECEIVED WITH A TORN BENDING SECTION COVER. ALL RETURNED DUODENOVIDEOSCOPES WERE SENT TO AN OFFSITE LABORATORY FOR MICROBIOLOGICAL TESTING. THE TJF-Q180V WITH SERIAL NUMBER (B)(4) WAS TESTING. THE TJF-Q180V WITH SERIAL NUMBER (B)(4) WAS TESTED POSITIVE FOR KLEBSIELLA PNEUMONIA. THE TWO TJF-160VFS DID NOT GROW ANY MICROORGANISMS. THE SUBJECT DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION HENCE THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF THE DEVICE IS RETURNED FOR EVALUATION OR ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE UPDATED. AS PART OF OUR INVESTIGATION WITH THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO OBSERVE THE USER FACILITY'S REPROCESSING PRACTICES AND PROVIDED REPROCESSING TRAINING PER THE USER FACILITY'S REQUEST. DURING THE ONSITE VISIT THE ESS OBSERVED THAT THE USER FACILITY STAFF WAS NOT PRE-CLEANING, LEAK TESTING, AND PRESSURIZING THE ENDOSCOPE BEFORE SUBMERGING THE DEVICE IN THE WATER. ADDITIONALLY, THE STAFF WAS NOT USING THE AIR/WATER CLEANING ADAPTER, NOR USING THE CORRECT SUCTION CLEANING ADAPTER. PLEASE CROSS REFERENCE MFR. REPORT # 8010047-2013-00172, 00173, 00174, 00176, AND 00177.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE CUSTOMER HAD CULTURED FOUR OF THEIR DUODENOVIDEOSCOPES AND THEY ARE FOLLOWS: MODELS TJF-Q180V, WITH THE FOLLOWING SERIAL NUMBERS: (B)(4) AFTER HIGH-LEVEL DISINFECTION AND THE DUODENOSCOPES TESTED POSITIVE FOR THE FOLLOWING BACTERIA: KLEBSIELLA PNEUMONIAE, PSEUDOMONAS AEROGINOSA, AND ENTEROCOCCUS. HOWEVER, THE USER FACILITY REPORTED THAT NOT ALL THREE DUODENOVIDEOSCOPES GREW ALL THREE ORGANISMS, BUT RATHER IT WAS A MIX. THE USER FACILITY FURTHER REPORTED THAT ONE OF THE 160 DUODENOVIDEOSCOPES ALSO CULTURED AND GREW KLEBSIELLA PNEUMONIAE. THE USER FACILITY FURTHER REPORTED THAT THERE WERE 15 CASES OF PT INFECTION AND THEY BELIEVED THAT IT IS RELATED TO THE DUODENOVIDEOSCOPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253347 OLYMPUS EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORPORATION TJF-Q180V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other