BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 2625940 · Received June 15, 2012

    Report

    Report Number
    8010047-2012-00194
    Event Type
    Other
    Date Received
    June 15, 2012
    Date of Event
    April 4, 2012
    Report Date
    May 18, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION. THE USER FACILITY REPORTED THAT THE AUXILIARY WATER CHANNEL WAS NOT BEING REPROCESSED DUE TO THE FLOW UNIT 2 ADAPTOR FROM STERIS WAS UNAVAILABLE. THE USER FACILITY REPORTED THAT THE 53 POTENTIALLY AFFECTED PATIENTS WERE NOTIFIED BUT HAVE NOT BEEN CULTURED AT THIS TIME. THERE HAD BEEN NO REPORT OF INFECTIONS AND PATIENT CROSS-CONTAMINATION. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS VISITED THIS FACILITY AND PROVIDED IN-SERVICE TRAINING REGARDING THE APPROPRIATE REPROCESSING OF ENDOSCOPE. NO PRODUCTS WERE RETURNED TO OLYMPUS FOR EVALUATION. IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME, THEN THIS REPORT WILL BE SUPPLEMENTED. OLYMPUS INSTRUCTION AND/OR REPROCESSING MANUALS PROVIDE DETAILED INFORMATION ON HOW TO REPROCESS THE SUBJECT ENDOSCOPE. THE CAUSE OF THIS REPORT APPEARS TO BE DUE TO USER ERROR. THIS IS ONE OF THREE REPORTS. PLEASE ALSO REFERENCE MFR REPORT # 8010047-2012-00192 AND 8010047-2012-00193. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THREE OLYMPUS ENDOSCOPES WERE BEING USED ON 53 PATIENTS IN WHICH THE AUXILIARY WATER CHANNELS WERE NOT BEING REPROCESSED AS THE USER FACILITY REPORTEDLY WAS UNABLE TO ACQUIRE AN UNIDENTIFIED ADAPTOR FROM STERIS FOR THE AUTOMATED ENDOSCOPE REPROCESSORS (AERS).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1