BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 1772205 · Received July 22, 2010

    Report

    Report Number
    8010047-2010-00144
    Event Type
    Other
    Date Received
    July 22, 2010
    Report Date
    June 23, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. AN OLYMPUS ENDOSCOPE SERVICE SPECIALIST (ESS) HAS VISITED THE FACILITY AND PROVIDED INSERVICING REGARDING THE APPROPRIATE REPROCESSING OF THE SUBJECT DEVICES. THE USER FACILITY'S INFECTION CONTROL DEPARTMENT HAS BEEN NOTIFIED AND IS REVIEWING THE MATTER. BASED UPON THE INFORMATION PROVIDED, THE USER FACILITY DID NOT REPROCESS THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE USER FACILITY WAS NOT REPROCESSING A 2-CHANNEL GASTROINTESTINAL VIDEOSCOPE IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THE USER FACILITY WAS REPORTED TO BE PERFORMING MANUAL REPROCESSING PRIOR TO PLACING THE DEVICES IN AN AUTOMATIC ENDOSCOPE REPROCESSOR (AER), HOWEVER, THEY WERE NOT REMOVING THE SUCTION SWITCHOVER LEVER FROM THE BIOPSY VALVE, AND WERE OCCLUDING THE BIOPSY PORTS OF THE INSTRUMENT CHANNELS DURING MANUAL CLEANING AND REPROCESSING IN THE AER. ADDITIONALLY, THE INSTRUMENT CHANNELS WERE REPORTEDLY NOT BEING FLUSHED ADEQUATELY. THE PRACTICE WAS SAID TO HAVE BEEN ONGOING FOR AN EXTENDED PERIOD OF TIME, POSSIBLY FROM THE TIME OF INITIAL PURCHASE OF THE GASTROVIDEOSCOPE. THERE WERE NO REPORTS OF ANY PATIENT INFECTIONS ASSOCIATED WITH THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORPORATION GIF-2T160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 THE ENDOSCOPES WERE SAID TO BE REPROCESSED IN A| MEDIVATORS DSD-201 AUTOMATIC ENDOSCOPE REPROCESSOR