BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO VIDEOSCOPE

    MDR report key: 23927751 · Received December 30, 2025

    Report

    Report Number
    9610595-2025-45123
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    November 12, 2024
    Report Date
    January 13, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FGB
    PMA / PMN Number
    K172246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS REPORTED BECAUSE SOMETHING IS STUCK INSIDE OF THE CHANNEL, WE DID THE WHOLE MANUAL CLEANING PROCESS AND WE HAVE A VERIFICATION SWAB IS WHAT BROKE OFF IN THE MIDDLE OF THE CHANNEL TOWARDS THE DISTAL TIP IT'S NOT VISIBLE. THE PRODUCT WAS RETURNED OLYMPUS SERVICE CENTER. THE PRODUCT ANALYSIS CONFIRMED THAT LEAK TEST DUNK TEST FAILED/UNABLE TO TAPED THE LEAK (A050402 - GAS/AIR LEAK, G04134 - TUBE). A-RUBBER BUNCHED UP/STRETCHED (A0405 - DEGRADED, G0405201 - ADHESIVE). A-RUBBER GLUE LIFTING AND SCRATCHES (A040102 - LOSS OF OR FAILURE TO BOND, G0405201 - ADHESIVE). FORCEPS PASSAGE STUCK FOREIGN MATERIAL INSIDE AND LEAKING DUE TO A TEAR WALL (A180306 - RESIDUE AFTER DECONTAMINATION, G04134 - TUBE). BRUSH PASSAGE NO PASS CLEANING BRUSH (A1408 - NO FLOW, G04134 - TUBE). ONE OR MORE FAILURE MODE(S) IDENTIFIED HAS BEEN PREVIOUSLY INVESTIGATED THROUGH THE PRODUCT TECHNICAL INVESTIGATION (PTI) PROCESS AND THEREFORE DOES NOT REQUIRE ANY FURTHER INVESTIGATION. SEE CODING TABLE FOR THE PTI REFERENCE NUMBER ASSOCIATED WITH THESE FAILURE MODES. A SHR REVIEW WAS NOT CONDUCTED ON THIS PREVIOUSLY SERVICED DEVICE AS THE COMPLAINT IS NOT RELATED TO A DEATH, INFECTION, OR PATIENT INJURY. A LABELING REVIEW IS NOT REQUIRED AS THERE IS NO EVIDENCE TO SUGGEST THAT THE USER MAY NOT HAVE PROPERLY HANDLED/USED THE DEVICE IN ACCORDANCE WITH THE IFU. A RISK REVIEW WAS NOT PERFORMED ON APPROPRIATE DEVICE PROBLEM TERM/CODE NOT AVAILABLE A180306 - RESIDUE AFTER DECONTAMINATION) AS FOREIGN MATERIAL IN TUBE. A COMPLAINT HISTORY REVIEW WAS NOT PERFORMED ON APPROPRIATE DEVICE PROBLEM TERM/CODE NOT AVAILABLE A180306 - RESIDUE AFTER DECONTAMINATION) AS FOREIGN MATERIAL IN TUBE. A CAPA, COMPLAINT AND RISK REVIEW WAS COMPLETED FOR THE REPORTED ALLEGATION OF -BRUSH PASSAGE NO PASS CLEANING BRUSH (A1408 - NO FLOW, G04134 - TUBE). FORCEPS PASSAGE STUCK FOREIGN MATERIAL INSIDE AND LEAKING DUE TO A TEAR WALL (A180306 - RESIDUE AFTER DECONTAMINATION, G04134 - TUBE) AND NO TRENDS WERE FOUND AND NO RELATED CAPAS WERE FOUND. THE COMPLAINT WAS CONFIRMED; THE DEVICE HAS FOREIGN MATERIAL STUCK INSIDE THE CHANNEL. IN ADDITION, THE CHANNEL IS LEAKING DUE TO A TEAR WALL INSIDE. THE MOST PROBABLE CAUSE OF THE COMPLAINT IS D15 - CAUSE NOT ESTABLISHED THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. DUE TO C1502 - DUST OR DIRT PROBLEM IDENTIFIED. NO FURTHER ESCALATION IS REQUIRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE EXHIBITED FOREIGN MATERIAL STUCK INSIDE THE FORCEPS PASSAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220524 URETERO-RENO VIDEOSCOPE URETERO-RENO VIDEOSCOPE FGB AIZU OLYMPUS CO., LTD. URF-V2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown