BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EVIS EXERA II PEDI VIDEO COLONSCOPE

    MDR report key: 3190851 · Received June 20, 2013

    Report

    Report Number
    8010047-2013-00186
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL DETAILS REGARDING THE REPORT WITH NO RESULTS. 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 WERE PERFORMING ALL THE STEPS OF COLONOSCOPE REPROCESSING IN ACCORDANCE WITH THE REPROCESSING MANUAL. IN ADDITION, THE ESS WAS INFORMED BY THE USER FACILITY THAT 4 PROCEDURES WERE PERFORMED THAT DAY AND THE DEVICE WAS ONLY USED ON TWO. IN ADDITION, THE USER FACILITY BELIEVES THAT THE COLITIS WAS PROBABLY PREEXISTING AND NOT A RESULTS OF THE PROCEDURES. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE DISTAL END UNIT, BENDING SECTION, BENDING SECTION GLUE, INSERTION TUBE, AND THE BIOPSY PORT WERE EXAMINED WITH A BOROSCOPE AND YELLOWISH RESIDUE BUILDUP WAS NOTED. IN ADDITION, THE CHANNEL MOUNT, SUCTION CYLINDER UNIT, SUCTION MOUTHPIECE, CHANNEL PIPE AND THE AUXILIARY PORT WERE EXAMINED AND YELLOWISH BUILDUP WAS ALSO NOTED. THE RESIDUAL BUILDUP WAS ATTRIBUTED TO INSUFFICIENT CLEANING AN IMPROPER REPROCESSING. THE DEVICE WAS REFURBISHED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT TWO PTS WERE DIAGNOSED WITH COLITIS AFTER HAVING UNDERGONE DIAGNOSTIC COLONOSCOPIES ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281647 OLYMPUS EVIS EXERA II PEDI VIDEO COLONSCOPE PEDIATRIC VIDEO COLONOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION PCF-Q180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other