BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 1993547 · Received January 20, 2011

    Report

    Report Number
    8010047-2011-00013
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED A TRANSIENT IMAGE LOSS. THE PHENOMENON WAS DETERMINED TO BE DUE TO A BROKEN AND FRAYED WIRE FOUND AT THE FLEXIBLE PRINTED CIRCUIT BOARD. THE FLEXIBLE PRINTED CIRCUIT BOARD WAS REPLACED AND THE UNIT OPERATED APPROPRIATELY. THE DEVICE WAS SERVICED AND WAS RETURNED TO THE USER FACILITY. 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, APPROXIMATELY HALFWAY THROUGH THE PROCEDURE THE USERS EXPERIENCED A COMPLETE LOSS OF IMAGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT ENDOSCOPE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORPORATION GIF-H180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1