BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS URETERO-RENO VIDEOSCOPE

    MDR report key: 2455475 · Received January 31, 2012

    Report

    Report Number
    8010047-2012-00023
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Report Date
    January 5, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER FACILITY STATED THAT THE REPORTED PHENOMENON COULD HAVE LIKELY OCCURRED DURING AN UROLOGY PROCEDURE AND THERE WAS NO PT INJURY REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE USER'S REPORT. THE MESH UNIT AT THE LOWER PORTION OF THE BENDING SECTION WAS DAMAGED WHICH CAUSED A TEAR ON THE BENDING COVER, AND A FRAYED WIRE WAS FOUND PROTRUDING FROM THE BENDING COVER, CAUSING A LEAKS. THE DAMAGE MESH UNIT WAS ATTRIBUTED TO PHYSICAL DAMAGE DUE TO USER HANDLING. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT "RUBBER ON TIP DAMAGED BY LASER". OLYMPUS FOLLOWED UP WITH THE USER FACILITY AND WAS INFORMED THAT THIS DEVICE HAD BEEN USED IN AN UNSPECIFIED UROLOGY PROCEDURE. THERE WAS NO PT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1