BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 2051335 · Received April 1, 2011

    Report

    Report Number
    8010047-2011-00066
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT WITHOUT SUCCESS. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE IMAGE WAS INVISIBLE. THE INSERTION TUBE WAS FOUND SEVERELY BUCKLED, DENTED, DISCOLORED, BLISTERED, AND TORN WITH THE METAL MESH EXPOSED WHICH WAS ATTRIBUTED TO PHYSICAL DAMAGE AND CHEMICAL DAMAGE. ADDITIONALLY, THE LIGHT GUIDE TUBE WAS NOTED WITH EXCESSIVE BUCKLES AND NUMEROUS BROKEN FRAYED WIRES WERE OBSERVED ON THE BENDING SECTION MESH ON THE INSERTION TUBE. ANGULATION WAS FOUND LOW DUE TO STRETCHED ANGULATION WIRES AND EXCESSIVE PLAYS WERE NOTED ON THE CONTROL KNOB. THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE DAMAGED CHARGED COUPLE DEVICE (CCD) UNIT DUE TO PHYSICAL DAMAGE AND EXTENSIVE USAGE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED TYPE OF PROCEDURE, THE USERS EXPERIENCED MULTIPLE COLOR LINES ON THE SCREEN WITH NO IMAGE DISPLAYING. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GASTROSCOPE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION GIF-160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1