BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS URETERO-RENO VIDEOSCOPE

    MDR report key: 2626035 · Received June 7, 2012

    Report

    Report Number
    8010047-2012-00151
    Event Type
    Malfunction
    Date Received
    June 7, 2012
    Date of Event
    April 20, 2012
    Report Date
    May 11, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THIS REPORT, AND WAS INFORMED THAT A TRANSURETHRAL URETERO-LITHOTRIPSY (TUL) PROCEDURE WAS PERFORMED IN THE PT. THERE WERE MANY CALCULUSES IN THE PT'S URETHRA REPORTEDLY. THE USER FACILITY REPORTED THAT THE URETEROSCOPE LIKELY GOT STUCK BETWEEN SOME CALCULUSES AND THE PT'S URETER WALL, AND CONSEQUENTLY DIFFICULTY REMOVING. OLYMPUS WAS INFORMED IN (B)(6) 2012 THAT THE PT WAS DOING FINE. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL REVEALED THAT THE BENDING SECTION COVER WAS SCRATCHED ON LIKELY WITH CALCULUSES. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE USER EXPERIENCED DIFFICULTY REMOVING THE URETEROSCOPE OUT OF THE PT'S URETHRA DURING A PROCEDURE. THE USER ATTEMPTED PULLING OUT THE URETEROSCOPE TOGETHER WITH AN ACCESS SHEATH FROM THE PT, BUT UNSUCCESSFULLY. THE URETEROSCOPE WAS SUCCESSFULLY REMOVED FROM THE PT BY SURGICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R OR 14FR)| COOK MEDICAL FLEXOR URETERAL ACCESS SHEATH (12FR