BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS URETERO-RENO VIDEOSCOPE

    MDR report key: 2577670 · Received May 11, 2012

    Report

    Report Number
    8010047-2012-00147
    Event Type
    Other
    Date Received
    May 11, 2012
    Date of Event
    April 13, 2012
    Report Date
    April 13, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THE REPORTED EVENT AND WAS PROVIDED WITH LIMITED INFO. THE USER FACILITY STAFF REPORTED THAT THE USER WAS A PRIVATE PRACTITIONER THAT PERFORMED THE PROCEDURE IN THEIR FACILITY. THE USER FACILITY STAFF REPORTED THAT THE FOREIGN MATERIAL WAS BROKEN INTO PIECES AND WAS RETRIEVED FROM THE PT'S KIDNEY WITH THE USER OF AN UNIDENTIFIED GRASPING FORCEPS. THE FOREIGN MATERIALS WERE SENT TO PATHOLOGY LAB FOR ANALYSIS. THE CONDITION OF THE PT IS UNK. NO FURTHER INFO PROVIDED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE INSTRUMENT CHANNEL OF THE DEVICE WAS EXAMINED USING A BAROSCOPE NO FOREIGN OBJECT OR MATERIAL WAS FOUND. THERE WAS A KINK, DAMAGE, SCRAPE MARK OR TEAR MARK FOUND INSIDE THE INSTRUMENT CHANNEL. THERE WERE NO SIGNS OF MISSING PARTS, OR COMPONENTS NOTED WITH THE DEVICE. THE BENDING SECTION WAS LEAKING DUE TO A CUT. THE DISTAL END COVER WAS CRACKED, PEELING AND DISCOLORED. THE BENDING SECTION MESH WAS FOUND DAMAGED AND BENT. THIS SCOPE WILL BE SERVICED AND RETURNED TO THE USER FACILITY. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. OLYMPUS WILL CONTINUE TO WORK WITH THE USER TO OBTAIN ADDITIONAL INFO. IF ADDITIONAL AND SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN EXCESS OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE A LONG SKINNY FOREIGN MATERIAL WAS DISLODGED FROM THE WORKING CHANNEL OF THE SCOPE AND FELL INSIDE THE PT'S KIDNEY. THE USERS REPORTED THAT THE FOREIGN MATERIAL APPEARED TO BE THE COATING FROM EITHER THE WORKING CHANNEL OF THE ENDOSCOPE, THE LASER FIBER, THE BASKET OR THE GUIDEWIRE. THE SIZE OF THE LASER FIBER USED DURING THE PROCEDURE WAS 365 MICRON. THERE WAS NO FURTHER INFO PROVIDED.

    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 UNK UHS SURGICAL SERVICES 365 BARE HOLMIUM LASER:| PRODUCT (B)(4) WITH LOT # LP-683