BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCU,MODULAR,IMAGE1 S X-LINK,US

    MDR report key: 24591113 · Received March 13, 2026

    Report

    Report Number
    2027009-2026-00551
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    February 16, 2026
    Report Date
    April 24, 2026
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FET
    UDI-DI
    04048551356562
    PMA / PMN Number
    K160044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE COMPLAINT ISSUE WAS DESCRIBED AS COULDN'T GET THE URETEROSCOPE IMAGE TO STAY UP. WOULD TOGGLE FROM THE CAMERA HEAD TO THE URETEROSCOPE, THE IMAGE WOULD POPULATE FOR A COUPLE SECONDS, AND THEN IT WOULD REVERT BACK TO THE KARL STORZ PAGE. THE CUSTOMER'S COMPLAINT WAS VERIFIED. A FUNCTIONAL TEST CONFIRMED THE CUSTOMER'S ISSUE WITH AN 11278 URETEROSCOPE. A VISUAL INSPECTION WAS UNABLE TO IDENTIFY ANY ISSUES. HOWEVER, IT WAS DISCOVERED THAT THE IMAGE DROP ISSUE COULD BE INDUCED BY MANIPULATING THE IML CONNECTOR. A VISUAL INSPECTION OF THE IML CONNECTOR DID NOT REVEAL ANY OBVIOUS ISSUES, AND AN ATTEMPT WAS MADE TO CLEAN THE CONNECTOR, BUT THE IMAGE DROPS STILL OCCURRED WHEN THE CABLE WAS MOVED. THE MOTHERBOARD WILL NEED TO BE REPLACED TO ADDRESS THE CUSTOMER'S ISSUE, SINCE THE IML CONNECTOR IS NOT A REPLACEABLE COMPONENT AT KSNA GOLETA. THE CAUSE OF THE ISSUE HAS BEEN DETERMINED AS INTERMITTENT IML CONNECTOR. 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. THIS INFORMATION IS REFLECTED IN SECTION D9. 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

    IT WAS REPORTED THAT THERE WERE INTERMITTING BLACKOUTS DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35829 CCU,MODULAR,IMAGE1 S X-LINK,US CCU,MODULAR,IMAGE1 S X-LINK,US FET KARL STORZ IMAGING TC301US 04048551356562

    Patients

    Seq Age Sex Outcome Treatment
    1