BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F88 URE-SD FLEXIBLE URETEROSCOPE

    MDR report key: 23023857 · Received September 11, 2025

    Report

    Report Number
    3038613058-2025-00002
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 13, 2025
    Report Date
    November 5, 2025
    Manufacturer
    SG ENDOSCOPY PTE LTD
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO TO REPORT INVESTIGATION FINDINGS, THE DEVICE WAS FOUND TO BE LEAKING UPON RECEIPT. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT THERE WAS A PUNCTURE HOLE IN THE WORKING CHANNEL, WHICH WAS DETERMINED TO BE THE CAUSE OF THE LEAK. IT IS STATED IN THE IFU UNDER WARNINGS: DURING THE PROCDURE TO "NOT USE THE DEVICE IF INTERFERENCE OR RESISTANCE IS FELT WHEN INSERTING A SURGICAL INSTRUMENT INTO THE WORKING CHANNEL. FORCING THE INSTRUMENT MAY CAUSE DAMANGE TO THE DEVICE OR HARM THE PATIENT". A PUNCTURE HOLE IN THE WORKING CHANNEL IS NOT EXPECTED DURING NORMAL USAGE OF THE DEVICE. 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

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE FAILED LEAK TEST DURING REPROCESSING AFTER ITS 2ND CASE. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2676660 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