BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO-URETERO-RENOSCOPE FLEX XC

    MDR report key: 23970551 · Received January 5, 2026

    Report

    Report Number
    9610617-2025-02408
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Report Date
    March 3, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FGB
    UDI-DI
    04048551344408
    PMA / PMN Number
    K141250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: A VISUAL AND FUNCTIONAL TEST WAS CARRIED OUT BY THE ASSESSMENT DEPARTMENT OF KST. THE HANDLE AND HOUSING SHOW SIGNS OF WEAR. THE VERTEBRA IS CRUSHED. THE ANGLE COVER IS MECHANICALLY DAMAGED AND LEAKING AS A RESULT. THE ENDOSCOPE SHOWS NO IMAGE. ADDITIONALLY, THE ENDOSCOPE WAS SENT TO KSE FOR AN 8D REPORT: KSE CONFIRMS DAMAGE TO THE VERTEBRAE AND ANGLE COVER. HOWEVER, THE LACK OF IMAGE OUTPUT COULD NOT BE CONFIRMED; THE IMAGE WAS PRESENT. THE ERROR DESCRIBED BY THE CUSTOMER " NO IMAGE" COULD BE CONFIRMED BY KST NOT BY KSE. THE REASON FOR THE IMAGE FAILURE WAS LIQUID THAT HAD PENETRATED THROUGH THE DAMAGED ANGLE COVER. THIS AFFECTED THE ELECTRONICS SO THAT NO IMAGE WAS OUTPUT. ONCE THE MOISTURE HAD EVAPORATED, THE ELECTRONICS WORKED AGAIN AND THE IMAGE WAS RESTORED. FOR THIS REASON, KSE COULD NOT CONFIRM THE IMAGE FAILURE. BASED ON THESE OBSERVATIONS, THE REPORTED FAILURES[?]IMAGE LOSS AND ANGLE COVER LEAK[?]CAN BE ATTRIBUTED TO IMPROPER MAINTENANCE AND HANDLING. NO FURTHER CORRECTIVE ACTIONS ARE RECOMMENDED CURRENTLY. THE ABOVE CONDUCTED INVESTIGATIONS DID NOT REVEAL A ROOT CAUSE RELATED TO THE LABELLING, THE DEVICE OR ITS HISTORY. ALL PRODUCTION RELATED QUALITY CHECKS WERE PASSED, AND NO NON-CONFORMITIES WERE IDENTIFIED IN THE DEVICES MANUFACTURING RECORDS. THE LABELLING WAS FOUND TO CONTAIN ADEQUATE INSTRUCTIONS AND WARNINGS. THE COMPLAINT HISTORY DID NOT REVEAL ANY PICKUP IN SIMILAR COMPLAINTS, NO TREND WAS IDENTIFIED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION G3. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT "THE DISTAL RUBBER COVER IS LEAKY, NO IMAGE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41303 VIDEO-URETERO-RENOSCOPE FLEX XC VIDEO-URETERO-RENOSCOPE FLEX XC FGB KARL STORZ SE & CO. KG 11278VS 04048551344408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown