BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EXIS EXERA COLONOVIDEOSCOPE

    MDR report key: 1314138 · Received February 13, 2009

    Report

    Report Number
    8010047-2009-00026
    Event Type
    Injury
    Date Received
    February 13, 2009
    Date of Event
    January 19, 2009
    Report Date
    January 27, 2009
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN OLYMPUS ENDOSCOPE SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO FURTHER INVESTIGATE THIS REPORT. THE ESS REPORTED OBSERVING DEVIATIONS FROM THE RECOMMENDED REPROCESSING PRACTICES. THE ESS PROVIDED TRAINING ON THE CORRECT REPROCESSING OF ENDOSCOPES, AND SUGGESTED THAT THE FACILITY OBTAIN SOME ADDITIONAL EQUIPMENT TO ENSURE THAT THE ENDOSCOPE WERE STORED PROPERLY BEFORE USE. THE USER FACILITY HAS ELECTED NOT TO RETURN THIS ENDOSCOPE TO OLYMPUS FOR INVESTIGATION, AS THERE WAS NO PROBLEM WITH THE DEVICE. THE USER FACILITY INDICATED THAT THE REPORTED EVENT WAS ATTRIBUTED TO THE AUTOMATED ENDOSCOPE REPROCESSOR (AER), AND FURTHER REPORTED THAT THEY DO NOT SUSPECT THE ENDOSCOPES. OLYMPUS WAS INFORMED THAT THE AER WAS RETURNED TO THE MANUFACTURER DUE TO AN EXCESSIVE CHEMICAL SMELL. THE USER FACILITY HAS INCORPORATED ADDITIONAL RINSES WITH STERILE WATER AND ALCOHOL THROUGH THE DEVICE CHANNELS TO REDUCE THE CHEMICAL SMELL. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION. THIS IS THE FOURTH OF FOUR INCIDENTS REPORTED BY THIS FACILITY AS PART OF THIS REPORT. SEE ALSO 8010047-2009-00023, 8010047-2009-00024, AND 8010047-2009-00025.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PT SUSTAINED CHEMICAL COLITIS AFTER UNDERGOING A DIAGNOSTIC COLONOSCOPY. FOLLOWING THE PROCEDURE, THE PT WAS SAID TO HAVE EXPERIENCED ABDOMINAL CRAMPING AND BLOODY DIARRHEA. THE PT RETURNED TO THE FACILITY THE NEXT DAY, AND WAS REFERRED TO THE HOSPITAL FOR CAT SCAN. THE PT WAS THEN DIAGNOSED WITH CHEMICAL COLITIS. THE PT WAS ADMITTED TO THE HOSPITAL AND WAS RELEASED AFTER TWO DAYS. THE PT IS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EXIS EXERA COLONOVIDEOSCOPE COLONOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION PCF-Q180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R