BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA SIGMOIDOVIDEOSCOPE

    MDR report key: 2102004 · Received May 19, 2011

    Report

    Report Number
    8010047-2011-00100
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS CONTACTED THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT WITHOUT SUCCESS. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND THE BENDING SECTION GLUE CRACKED WITH PINHOLES, WAS DISCOLORED, AND POROUS IN TEXTURE DUE TO CHEMICAL DAMAGE. THERE WERE NICKS AND SCRATCHES ON THE DISTAL END COVER AND ON THE NOZZLE. THE DISTAL END COVER WAS CRACKED AND FAILED THE INSULATION TEST. NO SHARP EDGES WERE NOTED ON THE INSERTION TUBE, BENDING SECTION GLUE OR THE DISTAL END UNIT. THE DEVICE HAS BEEN SERVICED AND RETURNED TO THE USER FACILITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER, BUNCHING RESULTING IN A PINCHING SENSATION COULD NOT BE RULED OUT 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 THE PT COMPLAINED OF A "SHARP PINCH," AND STATED THAT THE RING AROUND THE DISTAL TIP WAS NOT FLAT AND SMOOTH. AN UNSPECIFIED TYPE OF PROTECTOR WAS SAID TO HAVE BEEN USED WHEN THE PHYSICIAN WAS USING THE DEVICE. THERE WAS NO REPORT OF ANY PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA SIGMOIDOVIDEOSCOPE SIGMOIDSCOPE FDS OLYMPUS MEDICAL SYSTEM CORPORATION CF-Q160S NA

    Patients

    Seq Age Sex Outcome Treatment
    1