BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 2912925 · Received December 20, 2012

    Report

    Report Number
    8010047-2012-00453
    Event Type
    Other
    Date Received
    December 20, 2012
    Date of Event
    October 5, 2012
    Report Date
    November 21, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT, AND WAS INFORMED THAT THE DEVICE HAS BEEN CULTURED, BUT WAS NEGATIVE FOR GROWTH AT THE FACILITY. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION, AND WILL BE SENT TO AN INDEPENDENT MICROBIOLOGY LAB FOR MICROBIOLOGICAL TESTING. 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. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. CROSS REFERENCE MFR REPORT #: 8010047-2012-00452 AND 8010047-2012-00454 FOR OTHER RELATED REPORTS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO IDENTIFIED BILIARY SECRETIONS OF 3 PTS THAT UNDERWENT ERCP AT THE FACILITY AND TESTED POSITIVE FOR ESCHERICHIA COLI. THERE WAS NO REPORT OF INFECTIONS OR OTHER PT HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1