BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS URETERO-RENO VIDEOSCOPE

    MDR report key: 1760587 · Received July 13, 2010

    Report

    Report Number
    8010047-2010-00134
    Event Type
    Other
    Date Received
    July 13, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 21, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION FOUND THE BENDING COVER LEAKING DUE TO A TORN BENDING COVER AT THE DISTAL END. METAL BRAIDS IN THE BENDING SECTION WERE BUNCHED UP, BROKEN, AND SOME WERE OBSERVED TO BE PROTRUDING OUT FROM THE BENDING COVER. THE DISTAL END COVER WAS NOTED BURNT AND MELTED AT THE CHANNEL PIPE OPENING. THE DEVICE HAS BEEN FORWARDED TO THE ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER INVESTIGATION. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL FOLLOW. (B)(4).

    Description of Event or Problem · 1

    DURING A THERAPEUTIC URETEROSCOPY PROCEDURE, THE PHYSICIAN REPORTEDLY ATTEMPTED TO PASS THE URETERO-RENO VIDEOSCOPE THROUGH AN 11 FRENCH INNER DIAMETER ACCESS SHEATH. AS THE USERS WERE ATTEMPTING TO MOVE THROUGH A TIGHT SPOT, THE BENDING SECTION REPORTEDLY BECAME STUCK AND WAS DAMAGED. THERE WAS NO ALLEGATION OF PARTS/DEBRIS FALLING IN THE PATIENT. THE USERS REPORTEDLY COULD NOT REMOVE THE SCOPE. THE SHEATH AND VIDEOSCOPE WERE REMOVED SIMULTANEOUSLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN UNSPECIFIED FLEXIBLE ENDOSCOPE AND NO ACCESS SHEATH. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS URETERO-RENO VIDEOSCOPE URETERO-RENO VIDEOSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORPORATION URF-V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 (13FR OUTER DIAMETER)| MICROVASIVE ACCESS SHEATH| UNKNOWN MODEL, 11FR INNER DIAMETER| UNKNOWN MODEL, 11FR INNER DIAMETER| MICROVASIVE ACCESS SHEATH| (13FR OUTER DIAMETER)