BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F88 URE-SD FLEXIBLE URETEROSCOPE

    MDR report key: 25111594 · Received May 7, 2026

    Report

    Report Number
    3038613058-2026-00002
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 7, 2026
    Manufacturer
    SG ENDOSCOPY PTE LTD
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORDS FOR SUBJECT DEVICE WERE REVIEWED. DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTION CHECKS. NO MANUFACTURING DEVIATIONS WERE IDENTIFIED. SUBJECT DEVICE WAS RECEIVED AND SUCCESSFULLY DECONTAMINATED. VISUAL INSPECTION IDENTIFIED BUNCHING IN BENDING RUBBER. DEVICE EVALUATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    BUNCHING AND FLARING OF THE OUTER BENDING RUBBER JUST BELOW THE DISTAL TIP INSTEAD OF LYING FLUSH AND SMOOTH, INDICATING PARTIAL DELAMINATION OR LOOSENING OF THE OUTER RUBBER. THIS WAS NOTICED BEFORE THE CASE DURING SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572338 F88 URE-SD FLEXIBLE URETEROSCOPE FLEXIBLE URETEROSCOPE FGB SG ENDOSCOPY PTE LTD F88 E/LOTFG-102316

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown