BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA GASTROVIDEOSCOPE

    MDR report key: 1520494 · Received October 28, 2009

    Report

    Report Number
    8010047-2009-00214
    Event Type
    Other
    Date Received
    October 28, 2009
    Report Date
    September 30, 2009
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCK
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES WERE RETURNED TO OLYMPUS FOR EVALUATION IN ASSOCIATION WITH THIS REPORT. AN OLYMPUS ENDOSCOPE SPECIALIST (ESS) VISITED THE USER FACILITY, AND REVIEWED APPROPRIATE REPROCESSING WITH FACILITY PERSONNEL. BASED UPON THE INFO PROVIDED THE USER FACILITY PERSONNEL DID NOT REPROCESS THE DEVICE IN ACCORDANCE WITH THE RECOMMENDED REPROCESSING INSTRUCTIONS. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    USER FACILITY PERSONNEL REPORTED THEY HAD NOT BEEN REPROCESSING THE AUXILIARY WATER CHANNELS OF ENDOSCOPES AT THEIR FACILITY SINCE THE TIME OF PURCHASE. THERE WERE NO REPORTS OF INJURIES ASSOCIATED WITH THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA GASTROVIDEOSCOPE GASTROSCOPES GCK OLYMPUS MEDICAL SYSTEMS CORPORATION GIF-Q160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK