BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCU, MODULAR, IMAGE1 S CONNECT II, US

    MDR report key: 22472967 · Received July 10, 2025

    Report

    Report Number
    2027009-2025-01206
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Report Date
    September 16, 2025
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FET
    UDI-DI
    04048551422625
    PMA / PMN Number
    K233333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION WAS RETURNED 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).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE CUSTOMER'S COMPLAINT CANNOT BE VERIFIED. THE CUSTOMER'S UNIT WAS NOT RETURNED TO KSUS GOLETA FOR EVALUATION. DEVICES ASSOCIATED WITH THE REPORTED ISSUE ARE TC301US AND TC028. SINCE THE CUSTOMER'S UNIT WAS NOT RETURNED, KSUS - GOLETA CANNOT MAKE ANY DEFINITIVE CONCLUSIONS REGARDING THE "DESCRIPTION OF PROBLEM". SOME POSSIBLE REASONS THE CUSTOMER'S EQUIPMENT LOST THE IMAGE COULD BE THE FOLLOWING: INTERMITTENT EDAC CONNECTOR IN THE TC301 CAUSED BY CONTAMINATION/CORROSION/NORMAL WEAR AND TEAR. INTERMITTENT IML CABLE BETWEEN THE TC301US AND TC201US OR BETWEEN THE TC201US AND MONITOR. DIRTY/WORN/CONTAMINATED IML CONTACTS ON THE TC301US OR TC201US. INTERMITTENT CABLE IN THE CUSTOMER'S SCOPE. INTERMITTENT MOTHERBOARD CIRCUITRY IN THE CUSTOMER'S SCOPE. INTERMITTENT MOTHERBOARD CIRCUITRY IN THE CUSTOMER'S TC301US/TC201US. INTERMITTENT POWER SUPPLIES IN THE TC301US/TC201US. UNIDENTIFIED SOFTWARE BUG IN THE SCOPE/TC301US/TC201US/TC028. SINCE THE CUSTOMER'S EQUIPMENT WAS NOT RETURNED TO KSUS GOLETA FOR EVALUATION, THE CAUSE OF THE INTERMITTENT IMAGE COULD NOT BE IDENTIFIED AND THEREFORE, A ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION "WHEN FLEX XC1 WAS PLUGGED IN, AFTER ABOUT 15 MINUTES THE SCOPE IMAGE BEGAN TO GLITCH AND THEN WENT BACK TO BLUE DASHBOARD THEN BACK TO SCOPE IMAGE GLITCHING AGAIN!" THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD PARTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120465 CCU, MODULAR, IMAGE1 S CONNECT II, US CCU, MODULAR, IMAGE1 S CONNECT II, US FET KARL STORZ IMAGING TC201US 04048551422625

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown