BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F88 URE-RD FLEXIBLE URETEROSCOPE

    MDR report key: 23241352 · Received October 7, 2025

    Report

    Report Number
    3038613058-2025-00006
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 15, 2025
    Report Date
    November 6, 2025
    Manufacturer
    SG ENDOSCOPY PTE LTD
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 SUBJECT DEVICE WAS FOUND TO BE LEAKING. UPON VISUAL INSPECTION UNDER 10X MAGNIFICATION, IT WAS OBSERVED THAT THERE WERE TWO LOCATIONS WHERE THE BENDING SECTION RUBBER WAS DAMAGED, WHICH WAS DETERMINED TO BE THE CAUSE OF THE LEAK. THE RUBBER WAS REMOVED TO OBSERVE THE INNER SURFACE AND IT WAS FOUND THAT THE OUTER SURFACE HAD A MORE "LACERATION" TYPE DEFECT COMPARED TO THE INNER SURFACE, WHICH ONLY HAD A SMALL "INCISION" LIKE DEFECT. FROM THIS, IT WAS DETERMINED THAT THE BENDING RUBBER WAS DAMAGED FROM THE OUTSIDE. IT WAS DETERMINED THAT 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 INFORMATION 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
    2582899 F88 URE-RD FLEXIBLE URETEROSCOPE FLEXIBLE URETEROSCOPE FGB SG ENDOSCOPY PTE LTD F88 URE-RD E/LOTFG-101736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown