BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1243002 · Received November 20, 2008

    Report

    Report Number
    8010047-2008-00190
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 22, 2008
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WILL NOT BE RETURNED TO OLYMPUS FOR INVESTIGATION. THE USER FACILITY HAS ELECTED TO SEND THE DEVICE TO A THIRD PARTY SERVICE PROVIDER FOR REPAIR. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, NON-OLYMPUS PARTS AND/OR REPAIRS CANNOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE USER'S EXPERIENCE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. THE URF-P3 INSTRUCTIONAL MANUAL STATES: "OLYMPUS IS NOT LIABLE FOR ANY INJURY OR DAMAGE WHICH OCCURS AS A RESULT OF REPAIRS ATTEMPTED BY NON-OLYMPUS PERSONNEL."

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC URETEROSCOPY, TWO URETEROSCOPES MALFUNCTIONED. THE USERS STATED THAT THEY HAD USED AN INITIAL URETEROSCOPE TO SUCCESSFULLY PLACE A STENT INSIDE THE PT'S KIDNEY, BUT THE PHYSICIAN FELT THE DISTAL PORTION OF THE DEVICE WAS NOT FLEXIBLE ENOUGH TO PROCEED TO PERFORM A LITHOTRIPSY. THE PHYSICIAN REMOVED THE INITIAL DEVICE FROM THE PT AND UTILIZED THE SUBJECT URETEROSCOPE, TO PERFORM THE LITHOTRIPSY. HOWEVER, AS THE SUBJECT DEVICE REACHED THE TARGET AREA, THE IMAGE BECAME CLOUDY AND OBSTRUCTED. THE PROCEDURE WAS DELAYED FOR APPROX 75 MINUTES BEFORE BEING ABORTED AND RESCHEDULED. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS OES URETERO RENO FIBERSCOPE FGB OLYMPUS WINTER & IBE GMBH URF-P3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR OLYMPUS OES URETERO RENO FIBERSCOPE| DEVICE MODEL: URF-P3