BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F88 URE-SD FLEXIBLE URETEROSCOPE

    MDR report key: 24907288 · Received April 17, 2026

    Report

    Report Number
    3038613058-2026-00001
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 20, 2026
    Report Date
    April 17, 2026
    Manufacturer
    SG ENDOSCOPY PTE LTD
    Product Code
    FGB
    UDI-DI
    08881300750091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 BREACH IN BENDING RUBBER. DEVICE EVALUATION HAS BEEN COMPLETED. LEAK TEST CONFIRMED AIR LEAKAGE CONSISTENT WITH REPORTED COMPLAINT. WORKING CHANNEL INTEGRITY WAS ASSESSED BY FLUID FLUSH WITH DISTAL TIP BLOCKED, FLUID LEAKED FROM BENDING RUBBER BREACH, CONFIRMING RUBBER PERFORATION. BREACH OBSERVED TO BE LOCATED ON SIDE ADJACENT TO LIGHT GUIDE BUNDLE. ADDITIONAL VISUAL / FUNCTIONAL INSPECTION REVEALED THE FOLLOWING: LIGHT GUIDE FIBER DAMAGE WITH ITS SHEATH SHOWING SIGNS OF THERMAL DAMAGE, DAMAGED UV ADHESIVE AND SUTURE NEAR BENDING RUBBER BREACH, SUTURE FUSING AT ENDS (THERMAL DAMAGE PATTERN), NORMAL VIDEO SENSOR FUNCTION BUT WITH DIMINISHED LUMEN OUTPUT AS COMPARED TO AT MANUFACTURE. PHYSICAL EVIDENCE SUGGESTS LASER ACTIVATION WITHIN WORKING CHANNEL PERFORATED CHANNEL WALL, DAMAGED LIGHT GUIDE BUNDLE, AND BREACHED BENDING RUBBER. THERMAL SUTURE DAMAGE, LIGHT FIBRE SHEATH DAMAQE PATTERN, AND BREACH LOCATION ARE CONSISTENT WITH LASER FIRING INSIDE CHANNEL DURING USE. THERE ARE ZERO (0) PRIOR REPORTS OF LEAK ATTRIBUTED TO LASER ACTIVATION WITHIN WORKING CHANNEL. THIS IS THE FIRST OCCURRENCE. RISK ANALYSIS HAD PREVIOUSLY IDENTIFIED ACCIDENTAL LASER FIRING WITHIN DEVICE CHANNEL RISK. IFU CONTAINS WARNING: "WHEN USING LASER PROBES, MAKE SURE THE LASER POWER IS NOT ACTIVATED UNTIL THE PROBE TIP HAS FULLY EMERGED FROM THE WORKING CHANNEL, IS VISIBLE ON THE SURGICAL DISPLAY MONITOR, AND THE SURGICAL SITE IS CLEARLY IDENTIFIABLE. ACTIVATING THE LASER WHILE THE PROBE IS STILL IN THE WORKING CHANNEL COULD RESULT IN PATIENT INJURY AND DAMAGE THE FLEXIBLE URETEROSCOPE." EXISTING WARNING DEEMED ADEQUATE. CONTINUOUS COMPLAINT MONITORING WILL BE PERFORMED WITH TRENDING REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE DID NOT PASS THE LEAK TEST, LEAK FAILURE WAS NEAR THE DISTAL TIP. DEVICE WAS USED ONCE IN A URETEROSCOPY (WITH LASER) PROCEDURE PRIOR TO FAILURE. THERE IS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614885 F88 URE-SD FLEXIBLE URETEROSCOPE FLEXIBLE URETEROSCOPE FGB SG ENDOSCOPY PTE LTD F88 E/LOTFG-102278 08881300750091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown