BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS

    MDR report key: 1242504 · Received November 20, 2008

    Report

    Report Number
    8010047-2008-00193
    Event Type
    Other
    Date Received
    November 20, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 30, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COLONOSCOPE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. A BAROSCOPE WAS UTILIZED TO EXAMINE THE INTERNAL CHANNELS AND FOUND EVIDENCE OF DEBRIS AND RESIDUE INSIDE THE SUCTION CYLINDER. THE LIGHT GUIDE LENS WAS NOTED TO BE CHIPPED, AND NICKS AND DENTS WERE OBSERVED ON THE DISTAL END COVER. AN OLYMPUS ENDOSCOPE SUPPORT SPECIALIST (ESS) HAS VISITED THE USER FACILITY AND PROVIDED IN-SERVICE TRAINING TO THE HOSPITAL STAFF ON HOW TO PROPERLY REPROCESS AND MAINTAIN THE DEVICE. THE CAUSE OF THE PATIENT'S OUTCOME COULD NOT CONCLUSIVELY BE DETERMINED. HOWEVER, BASED UPON THE FINDINGS OF THE DEVICE INVESTIGATION, INSUFFICIENT REPROCESSING APPEARS TO HAVE BEEN A LIKELY FACTOR. 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 FOLLOWING A DIAGNOSTIC COLONOSCOPY, THE PATIENT EXPERIENCED ABDOMINAL PAIN. THE PATIENT WAS REPORTEDLY ADMITTED TO THE HOSPITAL THE SAME EVENING, AND A CT-SCAN REVEALED A THICKENED COLON. THE PATIENT REPORTEDLY SUSTAINED ULCERS AND COLITIS IN THE DESCENDING COLON. THE PATIENT WAS PROVIDED ANTIBIOTICS, AND WAS HOSPITALIZED FOR SIX CONSECUTIVE DAYS. THE PATIENT HAS BEEN DISCHARGED. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION CF-H180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization