BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 1709316 · Received May 27, 2010

    Report

    Report Number
    8010047-2010-00102
    Event Type
    Death
    Date Received
    May 27, 2010
    Date of Event
    April 23, 2010
    Report Date
    April 28, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY AND WAS INFORMED THE INTENDED PROCEDURE WAS NOT COMPLETED. OLYMPUS WAS ALSO INFORMED THAT THE PT LIKELY EXPIRED DUE TO PRE-EXISTING MEDICAL CONDITIONS. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE BENDING SECTION COVER GLUE WAS FOUND TO BE CRACKED AND DISCOLORED AND THE INSERTION TUBE WAS DENTED AND SCRATCHED. THERE WERE NICKS AND DENTS ON THE DISTAL END COVER OF THE COLONOVIDEOSCOPE, AND ONE OF THE LIGHT GUIDE LENSES WAS CHIPPED. SCRAPE AND SHEAR MARKS WERE PRESENT IN THE BIOPSY CHANNEL AT THE BENDING SECTION AREA, AND SLIGHT RESIDUE WAS FOUND INSIDE THE CHANNEL MOUNT AND SUCTION CYLINDER UNIT. THE DEVICE HAS BEEN SERVICED AND RETURNED TO THE USER FACILITY. OLYMPUS HAS SUBSEQUENTLY BEEN INFORMED THAT THE DEATH CERTIFICATE LISTED CARDIAC ARREST AS THE CAUSE OF DEATH FOR THE PT, AND THAT NO AUTOPSY WAS PERFORMED. THE CAUSE OF THE PT'S OUTCOME CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME, HOWEVER THE FINDINGS OF THE EVAL, AND THE CAUSE OF DEATH INDICATE THAT THE LIKELIHOOD THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT IS REMOTE. 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 DURING A THERAPEUTIC SIGMOIDOSCOPY, THE PT SUDDENLY BECAME BRADYCARDIC AND HYPERTENSIVE. THE USERS REPORTEDLY REMOVED THE ENDOSCOPE FROM THE PT, AND ADMINISTERED THE DRUG ATROPINE. HOWEVER, THE PT'S CONDITION WORSENED, AND THE PT SUBSEQUENTLY EXPIRED. THERE WERE NO ALLEGATIONS OF ANY DEVICE MALFUNCTION WITH THE ENDOSCOPE OR ANY OF THE UNSPECIFIED CONCOMITANT DEVICES USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE COLONOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION CF-H180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death