BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1082861 · Received July 25, 2008

    Report

    Report Number
    8010047-2008-00129
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 27, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THERE WAS NO UNUSUAL STIFFNESS NOTED WITH THE INSERTION TUBE OR CONTROL KNOB MOVEMENT. THERE WERE NO SHARP EDGES NOTED ON THE DEVICE. THERE WAS PLAY ON THE ANGULATION KNOBS AND VARIABLE STIFFNESS DUE TO STRETCHED ANGLE AND COIL WIRES. THE VARIABLE STIFFNESS FUNCTION WAS DETERMINED TO BE LOOSE DUE TO LOOSE SCREWS ON THE VARIABLE STIFFNESS COLLAR. SWITCH BUTTON #1 WAS FOUND TO BE LEAKING DUE TO A CUT; HOWEVER, THERE WAS NO EVIDENCE OF FLUID INVASION IN THE CONTROL BODY. THERE WERE CRACKS AND DISCOLORATION OF THE GLUE AROUND THE LENSES, WHICH WAS ATTRIBUTED TO CHEMICAL DAMAGE. THIS REPORT IS BEING REPORTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT ON HIS INITIAL USE OF THE SUBJECT DEVICE, AT THE END OF THE PROCEDURE, A LARGE HEMATOMA WAS OBSERVED IN THE SIGMOID FLEXURE OF A PEDIATRIC PATIENT. THE HEMATOMA WAS CONFIRMED BY ANOTHER PHYSICIAN. THE PATIENT WAS KEPT OVERNIGHT AT THE HOSPITAL FOR OBSERVATION. THE PATIENT'S HEMATOCRIT WAS SAID TO HAVE DROPPED BY APPROXIMATELY 10 - 15%; HOWEVER, THE PHYSICIAN STATED THAT THE HEMATOCRIT HAD REMAINED WITHIN NORMAL RANGES. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION PROVIDED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS COLONOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION PCF-Q180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization