BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCU,MODULAR,IMAGE1S 4U, CONNECT, INTL,CE

    MDR report key: 23021582 · Received September 10, 2025

    Report

    Report Number
    9610617-2025-01576
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Report Date
    October 8, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: THE DEVICE WAS SENT TO THE MANUFACTURER FOR INSPECTION. DURING THE MANUFACTURER'S TECHNICAL INSPECTION, THE ERROR DESCRIPTION PROVIDED BY THE CUSTOMER, "UNIT SWITCHES ON, BUT DOES NOT RESPOND" COULD BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE IS COMPONENT MALFUNCTIONING (FPGA U1 DEFECT) AS INVESTIGATED BY KARL STORZ US. BECAUSE THE CAUSE CANNOT BE DETERMINED IN THE QUALITY ASSURANCE TEAM, A PRODUCT IMPROVEMENT PROJECT IS STARTED (KU40091) AT KSUS. THE IFU IS STATING THIS "FAILURE OF PRODUCTS" CLEARLY. THE ABOVE INVESTIGATIONS DID NOT REVEAL A ROOT CAUSE RELATED TO THE LABELLING, OR THE DEVICE HISTORY. ALL PRODUCTION-RELATED QUALITY CHECKS WERE PASSED, AND NO NON-CONFORMITIES WERE IDENTIFIED IN THE DEVICE'S 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

    THE DEVICE IN QUESTION WAS RETURNED TO 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 "THE UNIT SWITCHES ON BUT DOES NOT RESPOND. NO OUTPUT VIDEO SIGNALS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468829 CCU,MODULAR,IMAGE1S 4U, CONNECT, INTL,CE CCU,MODULAR,IMAGE1S 4U, CONNECT, INTL,CE FET KARL STORZ SE & CO. KG TC201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown