BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 1241520 · Received November 21, 2008

    Report

    Report Number
    8010047-2008-00195
    Event Type
    Injury
    Date Received
    November 21, 2008
    Report Date
    October 29, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FTJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL DID NOT DUPLICATE THE USER'S REPORT OF SHARP DISTAL END. THE DISTAL END COVER WAS NOTED TO BE CRACKED, BUT THERE WAS NO SHARP SURFACED DETECTED. THE AIR/WATER NOZZLE WAS CHECKED AND FOUND TO BE IN GOOD CONDITION. THE UNIT WAS NOTED TO FAIL BOTH AIR AND ELECTRICAL LEAKAGE TESTING DUE TO THE CRACK IN THE DISTAL END COVER., THERE WERE TINY CHIPS AND OLD GLUE FOUND AROUND THE OBJECTIVE AND LIGHT GUIDE LENSES, BUT NO AREAS OF SHARPNESS DETECTED AT THESE LOCATIONS. THE CAUSE OF THE PT'S OUTCOME CANNOT CONCLUSIVELY BE DETERMINED. THE DEVICE HAS BEEN SERVICED AND RETURNED TO THE USER FACILITY. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC COLONOSCOPY, A METAL PIECE AT THE DISTAL END OF THE ENDOSCOPE CREATED A "RIP WITH A FLAP" ON THE MUCOSA OF THE PT'S COLON. OTHER MINOR TRAUMA WAS SAID TO BE NOTED, BUT NO SPECIFIC DETAILS WERE PROVIDED. THE FACILITY HAS BEEN CONTACTED BY BOTH PHONE AND IN WRITING FOR ADDITIONAL INFO, HOWEVER, NO ADDITIONAL INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS COLONOSCOPE FTJ OLYMPUS MEDICAL SYSTEMS CORPORATION CF-140L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK