BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1398423 · Received April 9, 2009

    Report

    Report Number
    8010047-2009-00066
    Event Type
    Malfunction
    Date Received
    April 9, 2009
    Date of Event
    March 10, 2009
    Report Date
    March 11, 2009
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION DID NOT DUPLICATE THE USER'S REPORT OF A FROZEN IMAGE, BUT DID CONFIRM THAT THE IMAGE COLORATION WAS BROWN, AND THE DEVICE PROVIDED POOR COLOR REPRODUCTION. THE IMAGE REMAINED PRESENT DURING THE EVALUATION. THERE WAS A DEEP CUT NOTED ON THE BENDING SECTION COVER, AND THE DISTAL END COVER WAS CRACKED. THE BENDING SECTION COVER WAS ALSO NOTED TO BE DISCOLORED, LIKELY A RESULT OF CHEMICAL DAMAGE. THE SMALL LIGHT GUIDE LENS WAS CHIPPED, AND THE UNIT FAILED ELECTRICAL LEAKAGE TESTING. THERE WAS MINOR BUCKLING, AND SCRATCHES ON THE INSERTION TUBE. THE CAUSE OF THIS PHENOMENON WAS LIKELY DUE TO AN EXTENSIVE USE AND PHYSICAL DAMAGE TO THE CHARGE COUPLED DEVICE UNIT. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY. THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN UPPER ESOPHAGOGASTRO DUODENOSCOPY (EGD) THE VIDEO IMAGE FROZE AND THE IMAGE BECAME BROWN THAT THEY COULD NOT VISUALIZE ANYTHING. AS A RESULT, THE GASTROSCOPE WAS WITHDRAWN FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE USE OF A DIFFERENT, BUT SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA GASTROVIDEOSCOPE GCK OLYMPUS MEDICAL SYSTEM CORPORATION GIF-Q160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1