BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F88 URE-RD FLEXIBLE URETEROSCOPE

    MDR report key: 23023861 · Received September 11, 2025

    Report

    Report Number
    3038613058-2025-00003
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 15, 2025
    Report Date
    November 5, 2025
    Manufacturer
    SG ENDOSCOPY PTE LTD
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT INVESTIGATION FINDINGS, THE DEVICE WAS FOUND TO HAVE FAILED LEAK TEST AND EXHIBITED SOME LOSS OF DEFLECTION ANGLE OF THE BENDING SECTION UPON RECEIPT, A BREACH WAS ALSO OBSERVED AT THE BENDING RUBBER. THE SUBJECT DEVICE WAS CONNECTED TO A CONSOLE, NO IMAGE WAS ABLE TO BE DISPLAYED ON THE MONITOR, HOWEVER AN ERROR CODE "E7-LED FAILURE DETECTED" WAS DISPLAYED INSTEAD OF THE REPORTED "E2-LOSS OF COMMUNICATION" ERROR. CABLE CONNECTOR PINS OF THE SUBJECT DEVICE WERE VISUALLY INSPECTED AND THERE WAS NO SIGNS OF DAMAGE OR DEFECTS. FURTHER INVESTIGATION SHOWED A DEFORMED WORKING CHANNEL AND SOME SIGNS OF CORROSION NEAR THE HANDLE BOARD, WHICH WAS ATTRIBUTED TO FLUID INGRESS FROM THE BREACH AT THE RUBBER. THE BREACH IN THE RUBBER IS NOT EXPECTED DURING NORMAL USAGE OF THE DEVICE. IT WAS DETERMINED THAT THE ISSUE WAS NOT DUE TO A DEFECT OF THE DEVICE OR MANUFACTURING PROCESS. THE ROOT CAUSE OF THE FLUID INGRESS CAUSING COMMUNICATION ERROR COULD NOT BE CONCLUSIVELY DETERMINED, BUT WAS ATTRIBUTED TO A USE ERROR BY THE USER.

    Additional Manufacturer Narrative · 0

    REVIEW OF PRODUCTION RECORDS DID NOT REVEAL ANY DEVIATIONS IN THE MANUFACTURING PROCESS. THE DEVICE PASSED ALL SPECIFICED ACCEPTANCE CRITERIA PRIOR TO RELEASE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE RECEIPT ANTICIPATED BUT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE WAS PERFORMING AS PER EXPECTED FOR 30 MINUTES, THEN IT BEGAN FLICKERING, BEFORE LOSING SIGNAL WITH AN "E2 LOSS OF COMMUNICATION" ERROR CODE SHOWING UP. A REPLACEMENT SCOPE WAS USED WITH NO ISSUES. THE SUBJECT DEVICE WAS FOUND TO HAVE FAILED LEAK TEST AFTER THE PROCEDURE DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2232619 F88 URE-RD FLEXIBLE URETEROSCOPE FLEXIBLE URETEROSCOPE FGB SG ENDOSCOPY PTE LTD F88 URE-RD E/LOTFG-101742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown