BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F88 URE-SD FLEXIBLE URETEROSCOPE

    MDR report key: 23015065 · Received September 10, 2025

    Report

    Report Number
    3038613058-2025-00001
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 11, 2025
    Report Date
    October 28, 2025
    Manufacturer
    SG ENDOSCOPY PTE LTD
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PRODUCTION RECORDS DID NOT REVEAL ANY DEVIATIONS IN THE MANUFACTURING PROCESS. THE DEVICE PASSED ALL SPECIFIED 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE INVESTIGATION. DEVICE WAS RETURNED AND THE COMPLAINT ON "COVER POPPED OUT" COULD BE CONFIRMED. UPON DISASSEMBLY OF THE COMPONENT, IT WAS FOUND THAT THE LOCKING NUT WAS LOOSE AND THE INTERIOR OF THE COMPONENT HAD SCRATCHES AT ONE SIDE. DEVICE WAS USED IN AT LEAST ONE PROCEDURE HENCE THE PROBABILITY OF THE NUT NOT BEING FULLY TIGHTENED DURING ASSEMBLY IS LOW. THE MOST PROBABLE ROOT CAUSE IS THOUGHT TO BE DUE TO A MISALIGNMENT OF THE LOCKING NUT TO THE COMPONENT CASUING THE SCREW THREAD TO NOT BE ENGAGED PROPERLY, HENCE CAUSING THE OBSERVED SCRATCH MARKS AND YET STILL HOLDING TOGETHER THE COMPONENT AND THE BODY. THE POPPED OUT COMPONENT LIKELY OCCURED DUE TO AIR PRESSURE FROM THE STERILIZATION PROCESS. PREVENTIVE MEASURES HAVE BEEN TAKEN IN THE FORM OF AWARENESS TRAINING AND CONTINOUS MONITORING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE FAILED LEAK TEST DURING REPROCESSING AFTER ITS SECOND USE. THE LEAK WAS OBSERVED AT THE HANDLE OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519591 F88 URE-SD FLEXIBLE URETEROSCOPE FLEXIBLE URETEROSCOPE FGB SG ENDOSCOPY PTE LTD F88 URE-SD E/LOTFG-101736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown