BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F88 URE-SD FLEXIBLE URETEROSCOPE

    MDR report key: 23197063 · Received October 1, 2025

    Report

    Report Number
    3038613058-2025-00004
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 2, 2025
    Report Date
    October 2, 2025
    Manufacturer
    SG ENDOSCOPY PTE LTD
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD REVIEW WAS PERFORMED. THERE IS NO INFORMATION THAT SUGGESTS ANY MANUFACTURING DEFECTS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE MANUFACTURED, INSPECTED, AND RELEASED IN ACCORDANCE WITH ESTABLISHED PROCEDURES AND ACCEPTANCE CRITERIA. REPORTED EVENT IS NOT CONFIRMED. SUBJECT DEVICE WAS RETURNED FOR EVALUATION, DURING RECEIPT, A PORTION OF A LASER FIBRE WAS FOUND TO BE LEFT WIHTIN THE WORKING CHANNEL OF THE SUBJECT DEVICE. VISUAL INSPECTION CONFIRMED THAT THE DISTAL TIP SECTION, INCLUDING THE CAMERA HOUSING IS UNDAMAGED. A SMALL HOLE (3MM) WAS OBSERVED ON THE INSERTION PORTION AT APPROXIMATELY 570MM AWAY FROM THE DISTAL TIP OF THE SUBJECT DEVICE. THE OUTER JACKET OF THE INSERTION TUBE IS MELTED, EXPOSING THE LIGHT GUIDE, EVIDENT OF LASER BURN. ILLUMINATION AND CAMERA FUNCTION WAS ABLE TO BE ACHIEVED WHEN THE DEVICE WAS CONNECTED TO A CONSOLE UNIT. LIGHT CAN BE SEEN AT THE DISTAL TIP, AND ALSO AT THE SMALL HOLE AT THE LASER BURN MARK. THE PROXIMAL END OF THE LASER FIBRE TERMINATES AT THE LOCATION OF THE HOLE, INDICATING THAT THE DAMAGE OCCURED WHEN THE LASER WAS APPLIED DURING THE PROCEDURE. FURTHER COMMUNICATION WITH THE IMPORTER REVEALED THAT THE SUBJECT DEVICE WAS USED TOGETHER WITH AN ACCESS SHEATH. DUE TO CHALLENGING ANGLE AND CONTINUOUS FORCE APPLIED, THE SHEATH BROKE, WHICH IN TURN DAMAGED THE DEVICE. THERE IS NO REPORT OF PATIENT INJURY. THE PROCEDURE WAS NOT COMPLETED, AND A FOLLOW-UP SURGERY WAS SCHEDULED FOR THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE TO REMOVE A STONE FROM THE PATIENT'S NEOBLADDER, "MULTIPLE SCOPES AND ACCESSORIES DAMAGED, TEARS IN THE EXTERNAL COVER AND SHEATH, TORE OFF THE CAMERA ITSELF". NO PATIENT INJURY WAS REPORTED. THE PROCEDURE WAS NOT COMPLETED, AND A FOLLOW-UP SURGERY WAS SCHEDULED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2458000 F88 URE-SD FLEXIBLE URETEROSCOPE FLEXIBLE URETEROSCOPE FGB SG ENDOSCOPY PTE LTD F88 URE-SD E/LOTFG-101734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown