BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F88 URE-RD FLEXIBLE URETEROSCOPE

    MDR report key: 23197080 · Received October 1, 2025

    Report

    Report Number
    3038613058-2025-00005
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 4, 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 COMPLAINT WAS CONFIRMED AS THE SUBJECT DEVICE FAILED THE LEAK TEST UPON RECEIPT. DURING THE LEAK TEST, SMALL AMOUNTS OF FLUID WAS OBSERVED TO LEAK OUT FROM THE BENDING RUBBER. VISUAL INSPECTION SHOWED THAT THE BENDING SECTION EXHIBITED OFF-AXIS DEFLECTION AND DAMAGE/DISLOCATIONS OF THE SEGMENTS OF THE BENDING SECTION. A FIBRESCOPE WAS PASSED THROUGH THE WORKING CHANNEL AND IT WAS OBSERVED THAT THERE WERE SIGNS OF DEFORMATION OF THE WORKING CHANNEL, LOCATION OF DEFORMATION COINCIDES WITH THE LOCATION OF THE BENDING SECTION DAMAGE/DISLOCATION. IT WAS DETERMINED THAT WORKING CHANNEL DEFORMATION IS NOT EXPECTED DURING NORMAL USE OF THE DEVICE, AND THE ISSUE WAS NOT DUE TO A DEFECT OF THE DEVICE OR MANUFACTURING PROCESS. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, BUT WAS ATTRIBUTED TO A USE ERROR BY THE USER.

    Additional Manufacturer Narrative · 0

    DESIGN HISTORY RECORDS REVIEW WAS PERFORMED, THERE WAS NO INFOMRATION THAT SUGGESTED THAT THE MANUFACTURING PROCESS HAD ANY RELATION TO THE REPORTED EVENT. THE DEVICE WAS MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE WITH ESTABLISHED PROCEDURES AND ACCEPTANCE CRITERIA. SUBJECT DEVICE HAS BEEN RECEIVED AND INVESTIGATIONS ARE ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE FAILED LEAK TESTING IN THE STERILE PROCESSING DEPARTMENT PRIOR TO REPROCESSING. THERE WAS NO REPORTS OF PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2459035 F88 URE-RD FLEXIBLE URETEROSCOPE FLEXIBLE URETEROSCOPE FGB SG ENDOSCOPY PTE LTD F88 URE-RD E/LOTFG-101734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown