BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F88 URE-SD FLEXIBLE URETEROSCOPE

    MDR report key: 23528886 · Received November 11, 2025

    Report

    Report Number
    3038613058-2025-00007
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 11, 2025
    Report Date
    December 11, 2025
    Manufacturer
    SG ENDOSCOPY PTE LTD
    Product Code
    FGB
    UDI-DI
    08881300750091
    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 SUBMITTED TO PROVIDE THE RESULTS OF THE INVESTIGATION CONDUCTED ON THE SUBJECT DEVICE. THE REPORTED COMPLAINT WAS CONFIRMED. THE DEVICE FAILED THE MANUAL LEAK TEST, AND IMMERSION IN WATER VERIFIED THE PRESENCE OF A LEAK ORIGINATING FROM THE BENDING RUBBER NEAR THE DISTAL TIP. A VISUAL INSPECTION UNDER 10× MAGNIFICATION IDENTIFIED A SMALL INCISION MEASURING APPROXIMATELY 0.5 MM ON THE BENDING RUBBER. TO FACILITATE FURTHER EVALUATION, THE BENDING RUBBER WAS REMOVED. UPON REMOVAL, IT WAS OBSERVED THAT THE UNDERLYING BENDING SECTION SEGMENT LOCATED BENEATH THE INCISION HAD ROTATED OUT OF ITS INTENDED POSITION. THIS ROTATIONAL DISPLACEMENT CAUSED CERTAIN METALLIC COMPONENTS TO PROTRUDE OUTWARD. THE PROTRUSION WAS DETERMINED TO BE THE CAUSE OF THE BENDING RUBBER DAMAGE, RESULTING FROM INCREASED MECHANICAL STRESS DURING BENDING SECTION ARTICULATION AND REPETITIVE ABRASIVE CUTTING INTERACTION WITH THE RUBBER MATERIAL. A SEGMENT DISLOCATION OF THIS NATURE IS CONSIDERED HIGHLY UNLIKELY TO OCCUR UNDER NORMAL USE CONDITIONS. BASED ON THE AVAILABLE EVIDENCE, THE ROOT CAUSE OF THE ROTATIONAL DISLOCATION WAS ATTRIBUTED TO USER ERROR, SPECIFICALLY THE APPLICATION OF EXCESSIVE ROTATIONAL FORCE TO THE BENDING RUBBER OR DISTAL TIP DURING DEVICE MANIPULATION.

    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. 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 TEST DURING REPROCESSING. THERE WAS NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932631 F88 URE-SD FLEXIBLE URETEROSCOPE FLEXIBLE URETEROSCOPE FGB SG ENDOSCOPY PTE LTD F88 E/LOTFG-101736 08881300750091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown