BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA II XENON LIGHT SOURCE

    MDR report key: 1586131 · Received January 21, 2010

    Report

    Report Number
    8010047-2010-00012
    Event Type
    Other
    Date Received
    January 21, 2010
    Report Date
    December 23, 2009
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT A PT HAD SUSTAINED A BOWEL PERFORATION FOLLOWING AN UNSPECIFIED PROCEDURE. NO FURTHER DETAILED INFO WAS PROVIDED TO DATE. OLYMPUS HAD FOLLOWED UP WITH THE USER FACILITY TO GATHER ADD'L INFO REGARDING THE EVENT, HOWEVER, ONLY LIMITED INFO WAS PROVIDED TO DATE. THE USERS INDICATED THAT THE PHENOMENON MAY HAVE BEEN RELATED TO THE PT'S MEDICAL CONDITION. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. IF THE DEVICE IS RECEIVED AT A LATER DATE, OR IF FURTHER SIGNIFICANT ADD'L INFO IS OBTAINED, THE REPORT WILL BE UPDATED. THE CAUSE OF THE USER'S EXPERIENCE COULD NOT CONCLUSIVELY BE DETERMINED, BUT THE PT'S PREDISPOSING MEDICAL CONDITIONS COULD NOT BE EXCLUDED AS A CONTRIBUTORY FACTOR. 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 A PT HAD SUSTAINED A BOWEL PERFORATION FOLLOWING AN UNSPECIFIED PROCEDURE. NO FURTHER DETAILED INFO WAS PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II XENON LIGHT SOURCE LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEMS CORPORATION CLV-180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Congenital Anomaly EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE| PROCEDURE.| SERIAL NUMBER UNK WAS REPORTEDLY USED DURING THE| MODEL PCF-H1801L