BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1220815 · Received October 30, 2008

    Report

    Report Number
    8010047-2008-00180
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 1, 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. THE INVESTIGATION CONFIRMED THE USER'S REPORT OF HALO EFFECT ON THE SCREEN. THE CHARGE COUPLED DISPLAY (CCD) UNIT AND OBJECTIVE LENS WERE NOTED TO HAVE SUNK INTO THE DISTAL TIP OF THE ENDOSCOPE, BUT REMAINED INTACT. A CCD SCREW WAS FOUND LOOSE, WHICH LIKELY RESULTED IN THE CCD SLIDING INTO THE ENDOSCOPE AS IT WAS MANIPULATED. THE HALO EFFECT AND CRESCENT IMAGE LIKELY RESULT FROM THE CCD SLIPPING INTO THE DEVICE. THERE WAS NO CRACK OR CHIP NOTED ON THE OBJECTIVE LENS. THE LIGHT GUIDE LENS ON THE DEVICE WAS FOUND CHIPPED. IN ADDITION, THERE WAS PHYSICAL DAMAGE NOTED ON THE DEVICE INCLUDING MULTIPLE DENTS AND SCRATCHES ON THE DISTAL TIP COVER, A CHIPPED LIGHT GUIDE LENS, AND STRETCHED ANGULATION AND PLAY ON THE CONTROL AND VARIABLE STIFFNESS KNOBS DUE TO EXTENDED USE. THE DEVICE WAS SERVICED AND WAS RETURNED TO THE FACILITY. THIS DEVICE IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    IN 2008, A PT WAS EXAMINED AT THE FACILITY DUE TO AN ABDOMINAL PAIN AND CONSTIPATION. THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC COLONOSCOPY, THE PHYSICIAN FELT SOMETHING MOVE INSIDE THE ENDOSCOPE, AND THE IMAGE THEN DEVELOPED A HALO EFFECT, AND A CRESCENT-SHAPED OBJECTS WAS OBSERVED ON THE VIDEO SCREEN. THE ENDOSCOPE WAS WITHDRAWN, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT, BUT SIMILAR DEVICE. THERE WERE NO REPORTED ANOMALIES NOTED DURING THE REMAINDER OF THE PROCEDURE. DURING REPROCESSING OF THE SUBJECT DEVICE, THE USER FACILITY'S TECHNICIAN OBSERVED WHAT HE/SHE BELIEVED TO BE TWO HOLES ON THE DISTAL TIP OF THE DEVICE. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR SERVICE. THE PT WAS LATER SENT TO X-RAY FOR EXAMINATION FOR THE PRESENCE OF ANY DEVICE FRAGMENTS. THE INITIAL X-RAY SHOWED THE PRESENCE OF AN UNIDENTIFIED DENSITY. THE PHYSICIAN REPORTEDLY DECIDED TO RE-EXAMINE THE PT WITH ANOTHER ENDOSCOPE, AND AN ENDOSCOPY PREP WAS SAID TO HAVE BEEN INITIATED. THREE DAYS LATER, PRIOR TO PERFORMING A RE-INSPECTION ENDOSCOPY PROCEDURE, ANOTHER X-RAY OF THE PT'S COLON WAS PERFORMED. HOWEVER THE SECOND X-RAY SHOW NO PRESENCE OF A DENSITY, AND, NO SECOND ENDOSCOPY WAS PERFORMED. THE PT IS REPORTEDLY DOING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR