BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EVIS EXERA COLONOVIDEOSCOPE

    MDR report key: 1871217 · Received October 11, 2010

    Report

    Report Number
    8010047-2010-00206
    Event Type
    Injury
    Date Received
    October 11, 2010
    Report Date
    September 14, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THE EVENT, BUT THE USER FACILITY PROVIDED VERY LIMITED INFO. OLYMPUS WAS INFORMED THAT THE USERS HAD REPORTEDLY RULED OUT THE COLONOSCOPE AS THE CAUSE OF THE PERFORATION, BUT COULD NOT CONCLUSIVELY DETERMINE THE CAUSE. AS PART OF OUR INVESTIGATION INTO THIS REPORT, AN OLYMPUS REPRESENTATIVE VISITED THE USER FACILITY TO EXAMINE THE VIDEO PROCESSOR AND LIGHT SOURCE USED DURING THE PROCEDURE, AND REPORTED NO ANOMALIES WERE NOTED ON THE EQUIPMENT. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. NOTED MINOR SCRAPES AND PEELING ON THE INSERTION TUBE, AND A SMALL CHIP IN ONE OF THE LIGHT GUIDE LENSES, HOWEVER NO SHARP SURFACES WERE DETECTED AND THE DEVICE WAS FOUND TO OPERATE APPROPRIATELY. THE DEVICE WAS SERVICED AND WAS RETURNED TO THE USER FACILITY. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. 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 COLONOSCOPY PROCEDURE, THE PT SUSTAINED A COLON PERFORATION. THE REPORTER ALSO STATED THAT THE COLONOSCOPE HAD BEEN RULED OUT AS THE SOURCE OF THE PERFORATION, HOWEVER THEY WISHED THE DEVICE TO BE EVALUATED. ADDITIONAL DETAILED INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MODEL OF "INSUFLATOR MACHINE."