BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS URETERO-RENO VIDEOSCOPE

    MDR report key: 1872131 · Received October 11, 2010

    Report

    Report Number
    8010047-2010-00203
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THAT THERE WAS NO IMAGE. FLUID WAS FOUND INSIDE THE CONTROL BODY AND IN THE BENDING SECTION. THE CHANNEL OPENING WAS NOTED TO BE CUT AND EXHIBITED BURN MARKS WHICH RESULTED IN FLUID INVASION. THE CHARGE-COUPLED DEVICE (CCD) WAS DETERMINED TO BE DAMAGED. THE REPORTED PHENOMENON APPEARS TO BE DUE TO USER MISHANDLING. (B)(4). THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO URETEROSCOPY PROCEDURE, THERE WAS A COMPLETE LOSS OF IMAGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT ENDOSCOPE. THERE WAS NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL GYRUS/ACMI URETEROSCOPE| UNK MODEL GYRUS/ACMI URETEROSCOPE