BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO VIDEOSCOPE

    MDR report key: 12791805 · Received November 10, 2021

    Report

    Report Number
    8010047-2021-14459
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Report Date
    November 11, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K072957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED AT SORC. AS A RESULT OF THE EVALUATION, THE FOLLOWING WAS CONFIRMED. -FOREIGN MATERIAL WAS COME OUT OF THE INSTRUMENT CHANNEL DUE TO A BLOCKAGE IN THE INSTRUMENT CHANNEL. -THE WATERTIGHTNESS WAS NOT MAINTAINED DUE TO A HOLE IN THE INSTRUMENT CHANNEL DUE TO EXTERNAL FACTORS. -THE CONTROL SECTION, REMOTE SWITCH, GRIP UNIT, UP/DOWN ANGULATION CONTROL LEVER, UP/DOWN PLATE, UNIVERSAL CORD, VIDEO CABLE, LIGHT GUIDE CONNECTOR, VIDEO CONNECTOR, AND UP/DOWN ANGULATION LOCK WERE SCRATCHED BY EXTERNAL FACTORS. -THE VIDEO CABLE WAS WRINKLED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CONFIRMED THE FOLLOWING FACTS. -DUE TO THE CLOGGING OF FOREIGN MATERIAL IN THE INSTRUMENT CHANNEL, THE ENDO-THERAPY ACCESSORY INSERTION FAILURE OCCURRED. -THERE WAS A LEAKAGE FROM THE INSTRUMENT CHANNEL DUE TO A HOLE IN THE INSTRUMENT CHANNEL. -OMSC COULD NOT DETERMINE WHETHER THE DEVICE WAS DAMAGED DUE TO STRESS OR HANDLING. -OMSC CONFIRMED THE MANUFACTURING RECORDS AND CONFIRMED THAT THE DEVICE WAS SHIPPED WITHOUT ANY MANUFACTURING ABNORMALITIES. FROM THE ABOVE, IT IS POSSIBLE THAT THE ENDO-THERAPY ACCESSORY INSERTION FAILURE OCCURRED DUE TO THE MIXING OF FOREIGN MATERIAL INTO THE INSTRUMENT CHANNEL DUE TO THE PERFORATION OF THE INSTRUMENT CHANNEL. HOWEVER, OMSC WAS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT, AS IT MAY HAVE BEEN CAUSED BY POOR CLEANING. OMSC REVIEWED THE REPAIR HISTORY AND CONFIRMED THAT THE FLEXIBLE TUBE, INSTRUMENT CHANNEL, CONTROL SECTION, GRIP COVER, UP / DOWN PLATE, LIGHT GUIDE BUNDLE, UNIVERSAL CORD, AND BENDING SECTION RUBBER WERE REPLACED ON MAY 20, 2020. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    THE USER RETURNED THE DEVICE TO OLYMPUS DUE TO A CLEANING BRUSH INSERTION FAILURE.OLYMPUS THEN INSPECTED THE DEVICE AT OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC) AND FOUND THAT THE ENDO-THERAPY ACCESSORY AND CLEANING BRUSH COULD NOT BE INSERTED BECAUSE THE INSTRUMENT CHANNEL WAS CLOGGED WITH FOREIGN MATERIAL.THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683947 URETERO-RENO VIDEOSCOPE URETERO-RENO VIDEOSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown