BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE VIDEO CYSTOSCOPE HD-VIEW

    MDR report key: 22297138 · Received June 20, 2025

    Report

    Report Number
    1221826-2025-01072
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Report Date
    March 16, 2026
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FAJ
    PMA / PMN Number
    K182723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    EXTERNAL TEST RESULTS INDICATED NO MICROBIOLOGICAL RESIDUES IN THE CHANNEL SYSTEM OR LUER. KSE INVESTIGATION SUMMARY STATES UNABLE TO CONFIRM REASON FOR RETURN AND ALL OTHER DEFECTS RECORDED ARE NOT A RESULT OF MATERIAL, COMPONENT, OR MANUFACTURING DEFICIENCY AS THE EVENT IS NOT INDICATIVE OF A PRODUCTION OR MATERIAL RELATED ISSUE. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINIC HAS NOTICED AN INCREASE IN POST PROCEDURE INFECTIONS IN THE LAST 2 MONTHS. THE CLINIC HAS CONFIRMED THERE WERE ISSUES WITH THE WAY THEY WERE CLEANING AND STERILIZING THE SCOPE, BUT THEY WANT ALL NEW SCOPES TO BE SAFE. HLD NOT COMPATIBLE FOR OUR SCOPES WAS USED AND THE STAFF WEREN'T CLEANING AND STERILIZING THE SCOPES PER OUR IFU. THE CLINIC DID NOT INFORM OF A SPECIFIC PROCEDURE IF THE FLEXIBLE CYSTOSCOPES ARE BEING USED IT CAN BE ANYTHING FROM A REGULAR CYSTOSCOPY, STENT REMOVAL OR PLACEMENT.. NO EVENT DATES WERE PROVIDED. THE CLINIC JUST SAW THE TREND INCREASE WITHIN THE LAST 2 MONTHS OR SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078237 FLEXIBLE VIDEO CYSTOSCOPE HD-VIEW FLEXIBLE VIDEO CYSTOSCOPE HD-VIEW FAJ KARL STORZ ENDOVISION R11272VHUK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other