BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 2088281 · Received May 2, 2011

    Report

    Report Number
    8010047-2011-00088
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION FOUND THE IMAGE INTERMITTENTLY DISTORTED AND LOST WHEN THE CONTROL KNOBS AND BENDING SECTION WERE MANIPULATED. THERE WAS EVIDENCE OF FLUID INVASION INSIDE THE ENDOSCOPE CONNECTOR UNIT, WHICH LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED IMAGE DIFFICULTIES, HOWEVER, THE DEVICE WAS NOTED TO PASS LEAKAGE TESTING. AS THE DEVICE PASSED LEAK TESTING THE LIKELY SOURCE OF THE FLUID INVASION APPEARS TO BE DUE TO MISHANDLING, LIKELY DURING REPROCESSING. 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 AN UNSPECIFIED ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE USERS EXPERIENCED A COMPLETE LOSS OF IMAGE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR BUT DIFFERENT ENDOSCOPE. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROSCOPE GCK OLYMPUS MEDICAL SYSTEM CORPORATION GIF-H180J NA

    Patients

    Seq Age Sex Outcome Treatment
    1