BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVIS EXERA 111 COLONOVIDEOSCOPE

    MDR report key: 3142275 · Received May 23, 2013

    Report

    Report Number
    8010047-2013-00129
    Event Type
    Other
    Date Received
    May 23, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 26, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE DISTRIBUTOR IN THE NETHERLANDS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE DISTRIBUTOR REPORTED THAT RECALLED PT WAS EXAMINED FOR CHECKING INFECTION AND THE RESULT WAS NEGATIVE. THE REFERENCED DEVICE WAS RETURNED TO OLYMPUS EUROPE FOR EVAL. THE EVAL DID NOT FIND ANY DEFECT IN THE CHANNEL. THERE WAS A CRACK AT PART OF THE DISTAL END DUE TO PHYSICAL DAMAGE. THE ANGULATION MECHANISM HAD TOO MUCH PLAY. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE DETERMINED; HOWEVER, USER HANDLING AND/OR MAINTENANCE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN THE ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING THE CHECKING OF THE DEVICE BEFORE PERFORMING A COLONOSCOPY, SOME INK WAS COMING OUT OF THE ENDOSCOPE. THE SCHEDULED PROCEDURE WAS FINISHED USING A DIFFERENT ENDOSCOPE. THE INK WAS USED FOR 2 PTS EARLIER TO MARK A TUMOR IN THE COLON. THE PT BETWEEN THE USAGE OF THE INK AND DISCOVERY OF THE INK IN THE ENDOSCOPE WILL BE RECALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227965 EVIS EXERA 111 COLONOVIDEOSCOPE COLOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORPORATION CF-HQ190L NA

    Patients

    Seq Age Sex Outcome Treatment
    1