BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCU, MODULAR, IMAGE1 S CONNECT II, US

    MDR report key: 22666437 · Received July 30, 2025

    Report

    Report Number
    2027009-2025-01322
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 30, 2025
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FET
    UDI-DI
    04048551422625
    PMA / PMN Number
    K233333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE CUSTOMER'S COMPLAINT WAS VERIFIED. THE TC201US WAS NOT PRODUCING AN IMAGE. THE CUSTOMER RETURNED THE FOLLOWING DEVICES, WHICH WERE ALL TESTED TOGETHER: TC201US, TC200US AND TC301US. THE RETURNED TC201US UNIT HAD AN IML/DISPLAY PORT CONNECTOR THAT WAS EXTREMELY DUSTY WITH DEBRIS. THIS CONNECTOR WAS CLEANED BY BLOWING OUT THE LOOSE DEBRIS WITH COMPRESSED AIR, AND THEN LIGHTLY SCRUBBED WITH ALCOHOL AND NYLON BRUSH. AFTER IML/DISPLAY PORT CLEANING, THE DISPLAY MODULE WAS TESTED AND THEN PRODUCED SOLID IMAGES, AND CABLE MANIPULATION WAS UNABLE TO IMPACT THE IMAGE QUALITY. THE CAUSE OF THE ISSUE WAS DETERMINED AS IMPROPER STERILIZATION/CLEANING BY THE CUSTOMER. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "UNITS ARE GOING BLACK/BLANK WHEN A CAMERA IS PLUGGED IN. CUT OUT IN MIDDLE OF PROCEDURE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45982 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