BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA II GASTROINTESTINAL VIDEOSC

    MDR report key: 2359977 · Received November 23, 2011

    Report

    Report Number
    8010047-2011-00299
    Event Type
    Other
    Date Received
    November 23, 2011
    Date of Event
    August 9, 2011
    Report Date
    October 26, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE, IN WRITING AND A SITE VISIT TO GATHER ADDITIONAL INFO REGARDING THIS EVENT, PLEASE REFERENCE MFR# 8010047-2011-00208 AND MEDWATCH REPORT NUMBER (B)(4) FOR FURTHER INFO. THE DEVICE REFERENCE IN THIS REPORT WAS RETURNED FOR EVALUATION. THE EVALUATION FOUND THE INSTRUMENT CHANNEL LEAKING TOWARD THE DISTAL END. THE CHANNEL WAS EXAMINED AND TEAR MARKS WERE OBSERVED ON THE CHANNEL WALL AT THE BENDING SECTION. THIS PHENOMENON IS DUE TO PHYSICAL DAMAGE. DRIED RESIDUE WAS NOTED ON THE OBJECTIVE LENS, HOWEVER THE DRIED RESIDUE DID NOT AFFECT THE IMAGE. THERE WERE SCRATCHES AND DENTS ON THE DISTAL END COVER, OBJECTIVE LENS GLUE, AND LIGHT GUIDE LENS GLUE. THE DISTAL END COVER AND INSERTION TUBE PASSED INSULATION TESTING. THERE WERE NO PROBLEMS WITH THE ANGULATION CONTROLS. THE INSERTION TUBE AND DISTAL END COVER PASSED INSULATION TESTING. THE AIR AND WATER FLOW CAPACITIES WERE BOTH WITHIN THE STANDARDS, AND WAS THE SUCTION FLOW. THE EVALUATION FOUND NO SIGNS OF SHARPNESS WITH THE NOZZLE. THERE WAS APPROX 10% LIGHT GUIDE BUNDLE BREAKAGE BUT THIS DID NOT SIGNIFICANTLY IMPACT THE LIGHT TRANSMISSION. THERE WERE NO FINDINGS THAT WOULD LIKELY CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE DEVICE HAS BEEN SERVICED AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE SUBJECT DEVICE OF THIS REPORT HAD BEEN USED IN TWO PROCEDURES IN WHICH THE PT WAS SAID TO HAVE EXPERIENCED AN AIR EMBOLISM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 LIGHT SOURCE: CLV-180, (B)(4)| VIDEO SYSTEMS CENTER CV-180, (B)(4)| GIF-1TQ160 (B)(4)| OLYMPUS DUODENOVIDEOSCOPE TJF-160F:| (B)(4)