BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA COLONOVIDEOSCOPE

    MDR report key: 2650376 · Received July 2, 2012

    Report

    Report Number
    8010047-2012-00209
    Event Type
    Other
    Date Received
    July 2, 2012
    Report Date
    June 4, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT BUT WITH NO RESULT. THE DEVICE REFERENCE IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. A REVIEW OF THE INSTRUMENT HISTORY SHOWED THAT THE DEVICE WAS LAST SENT TO OLYMPUS FOR SERVICE ON 04/25/2006 AND THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS SINCE THEN. THE USER FACILITY IS KNOWN TO HAVE BEEN USING A THIRD PARTY SERVICE PROVIDER. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. AS PART OF OUR INVESTIGATION INTO THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) HAS BEEN DISPATCHED TO VISIT THE USER FACILITY TO ASSESS THEIR REPROCESSING PRACTICES AND PROVIDE NECESSARY REPROCESSING TRAINING TO THE STAFF. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PIECE OF MUCOSA CAME OUT OF THE CHANNEL OF THE COLONOSCOPE DURING AN UNSPECIFIED PROCEDURE. THE CUSTOMER WAS NOT SURE IF THE MUCOSA WAS FROM A PREVIOUS PROCEDURE OR FROM THE CURRENT PT BEING EXAMINED. THE USER REPORTED THAT THE COLONOSCOPE WAS REPROCESSED IN A MEDIVATOR'S EDGE AUTOMATED ENDOSCOPE REPROCESSOR (AER). THERE WAS NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA COLONOVIDEOSCOPE COLONOSCOPE FDF OLYMPUS MEDICAL SYSTEM CORP CF-Q160AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK