BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EVIS EXERA II COLONVIDEOSCOPE

    MDR report key: 2872558 · Received December 5, 2012

    Report

    Report Number
    8010047-2012-00470
    Event Type
    Injury
    Date Received
    December 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADD¿L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT SIX PATIENTS WHO HAD UNDERGONE COLONOSCOPY WITH THE REFERENCED DEVICE WERE NOTED WITH LACERATIONS IN THE COLON. THE USER FACILITY CLAIMED THAT THE LACERATIONS WERE MICROSCOPIC. THE USER FACILITY REPORTED THAT NONE OF THE PTS REQUIRED INTERVENTION AND NO PATIENTS WERE AT RISK. THE USER FACILITY REPORTED THAT THERE SEEM TO BE A ROUGH EDGE ON THE DISTAL END OF THE REFERENCED DEVICE. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL DID NOT CONFIRM THE USER¿S REPORT. THERE WAS NO SCRATCH OR SMEAR NOTED WITH THE OBJECTIVE AND LIGHT-GUIDE LENS. HOWEVER, THE OBJECTIVE LENS GLUE WAS CRACKED AND CHIPPED, AND THE DISTAL-END COVER WAS NOTED WITH INDENTATION WHICH WAS ATTRIBUTED TO MISHANDLING. THE BENDING SECTION GLUE, BENDING SECTION, NOZZLE, AND THE INSERTION TUBE WERE OBSERVED WITH NO SHARP EDGES. THERE WERE SOME DISCOLORATION FOUND ON THE BENDING SECTION GLUE AND ON THE LIGHT-GUIDE LENS GLUE WHICH WAS ATTRIBUTED TO CHEMICAL DAMAGE. THE REFERENCED DEVICE PASSED THE GAUZE PAD EVALUATION. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT SMALL LACERATIONS AND ¿RUB MARKS¿ IN COLON WERE NOTICED OVER THE PAST TWO WEEKS. THE DISTAL END SEEMED SCRATCHED. THERE WAS NO FURTHER DETAIL PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II COLONVIDEOSCOPE COLONOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION CF-Q180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1