BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS EVIS EXERA II GASTROVIDEOSCOPE

    MDR report key: 2337015 · Received November 10, 2011

    Report

    Report Number
    8010047-2011-00275
    Event Type
    Death
    Date Received
    November 10, 2011
    Date of Event
    October 17, 2011
    Report Date
    October 20, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THE REPORT, AND WAS INFORMED THAT THE PT HAD UNDERGONE EITHER A WHIPPLE PROCEDURE OR ERCP, REPORTEDLY EXPERIENCED AN AIR EMBOLISM DURING THE PROCEDURE. THE PT WAS RESUSCITATED FOR 40 MINUTES, THEN TAKEN TO CT SCAN WHERE THE DIAGNOSIS WAS MADE. THE PT WAS THEN TRANSFERRED TO INTENSIVE CARE UNIT (ICU) WHERE HE ARRESTED AGAIN AND EXPIRED. THE GASTROSCOPE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE INITIAL EVAL OF THE GASTROSCOPE OBSERVED A LEAK FROM THE BIOPSY CHANNEL, BUT THIS FINDING COULD NOT BE REPEATED IN SUBSEQUENT LEAK TESTING. THE INTERNAL CHANNELS OF THE GASTROSCOPE WAS EXAMINED AND TEAR MARKS WERE OBSERVED IN THE BENDING SECTION AREA OF THE INSTRUMENT CHANNEL. THERE WERE DEEP SCRATCHES ON THE GLUE AROUND THE OBJECTIVE LENS AND LIGHT GUIDE LENSES. THERE WAS EVIDENCE OF DRIED RESIDUE ON THE OBJECTIVE LENS, BUT THIS FINDING WAS FOUND NOT TO AFFECT THE IMAGE. THERE WERE DENTS AND SCRATCHES NOTED ON THE DISTAL END COVER. THE DEVICE PASSED THE INSULATION TEST. THE AIR/WATER NOZZLE WAS INSPECTED AND NO SHARP EDGES WERE DETECTED. THE AIR AND WATER FLOW WERE WITHIN STANDARD, AS WAS SUCTION FLOW. THE FINDINGS OF THE EVAL WOULD NOT APPEAR LIKELY TO CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE EXACT CAUSE OF THE PT OUTCOME COULD NOT BE DETERMINED. THIS REPORT IS BEING SUBMITTED AS A MDR IN AN ABUNDANCE OF CAUTION. SEE ALSO MFR. REPORT NUMBER 8010047-2011-00276 FOR RELATED REPORT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING WHAT WAS DESCRIBED AS A WHIPPLE PROCEDURE THE PT HAD REPORTEDLY EXPERIENCED AN AIR EMBOLISM AND EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death CV-180: SERIAL NUMBER (B)(4)| CLV-180: SERIAL NUMBER (B)(4)