BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 2140316 · Received June 15, 2011

    Report

    Report Number
    8010047-2011-00129
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO GATHER ADD'L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE IMAGE BECAME COMPLETELY GRAYISH AS THE SUBJECT DEVICE REACHED THE STOMACH. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND THE IMAGE FOGGY IN THE CENTER DUE TO MOISTURE INSIDE THE OBJECTIVE LENS. THE SUBJECT DEVICE PASSED THE LEAK TEST. THE BENDING SECTION GLUE WAS DISCOLORED CONSISTENT WITH CHEMICAL DAMAGE, AND THE LIGHT-GUIDE TUBE WAS DENTED. THE SOURCE OF THE FLUID INGRESS WAS ATTRIBUTED TO THE DAMAGED BENDING SECTION GLUE. THE DEVICE HAS BEEN SERVICED AND RETURNED TO THE USER FACILITY. THE REPORTED PHENOMENON WAS ATTRIBUTED TO CHEMICAL DAMAGE. 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 DURING A DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE IMAGE TURNED COMPLETELY GRAY. THE INTENDED PROCEDURE WAS COMPLETED WITH A DIFFERENT BUT SIMILAR OLYMPUS GASTROSCOPE. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GASTROSCOPE GCK OLYMPUS MEDICAL SYSTEM CORPORATION GIF-160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE| UNSPECIFIED MODEL AND SERIAL NUMBERS OF OLYMPUS