BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS EVIS EXERA XENON COLONOVIDEOSCOPE

    MDR report key: 3221176 · Received July 3, 2013

    Report

    Report Number
    8010047-2013-00221
    Event Type
    Death
    Date Received
    July 3, 2013
    Date of Event
    April 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL HAS NOT YET BEEN COMPLETED. THIS REPORT WILL BE SUPPLEMENTED ONCE THE EVAL RESULTS BECOME AVAILABLE. ACCORDING TO THE DEVICE'S SERVICE HISTORY, THE REFERENCED DEVICE WAS LAST SERVICED ON (B)(6) 2013 DURING WHICH THE EVAL FOUND THAT THE DISTAL END COVER WAS CRACKED AND THE NOZZLE WAS CLOGGED. ADDITIONALLY, PEELING WAS OBSERVED ON THE LIGHT GUIDE TUBE. THE DEVICE WAS REPAIRED AND RETURNED TO THE FACILITY. PLEASE ALSO CROSS REFERENCE 8010047-2013-00220, AND 8010047-2013-00222.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED VIA LEGAL CORRESPONDENCE THAT THE PT DIED AFTER UNDERGOING A COLONOSCOPY PROCEDURE ON (B)(6) 2013 AT (B)(6) GASTROENTEROLOGY SPECIALISTS IN (B)(6). NO FURTHER INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303439 OLYMPUS EVIS EXERA XENON COLONOVIDEOSCOPE COLONOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION PCF-160AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death