BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS URETERO-RENO VIDEOSCOPE

    MDR report key: 2539087 · Received April 5, 2012

    Report

    Report Number
    8010047-2012-00110
    Event Type
    Malfunction
    Date Received
    April 5, 2012
    Date of Event
    March 6, 2012
    Report Date
    March 7, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADD'L INFO, AND WAS INFORMED THAT THE PT WAS UNHARMED, BUT THERE WAS NO ADD'L DETAILED INFO PROVIDED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND THE BENDING COVER WAS TORN AND THERE WAS DAMAGE ON THE MESH UNIT AT THE LOWER PORTION OF THE BENDING SECTION. THERE WERE SHARP FRAYED WIRES PROTRUDING FROM THE BENDING COVER WHICH CAUSED THE DEVICE TO LEAK. THE DAMAGED MESH UNIT WAS DETERMINED TO BE DUE TO PHYSICAL DAMAGE. THE DEVICE WAS REFURBISHED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE DEVICE WAS USED DURING AN UNIDENTIFIED PROCEDURE IN WHICH THE DEVICE WAS REPORTEDLY BROKEN. THERE WAS NO FURTHER DETAIL PROVIDED, AND NO REPORT OF PT HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1