BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21834360 · Received April 14, 2025

    Report

    Report Number
    9610617-2025-00623
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Report Date
    September 8, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FET
    PMA / PMN Number
    K160044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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).

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: DURING THE TECHNICAL INVESTIGATION OF THE RETURNED PRODUCT, THE FOLLOWING WAS FOUND: THE MOST PROBABLE ROOT CAUSE IS A COMPONENT FAILURE (FPGA DEFECT. A PRODUCT IMPROVEMENT PROJECT IS STARTED. THE CONDUCTED INVESTIGATIONS DID NOT REVEAL A ROOT CAUSE RELATED TO THE LABELLING OR DEVICE HISTORY. ALL PRODUCTION RELATED QUALITY CHECKS WERE PASSED AND NO NON-CONFORMITIES WERE IDENTIFIED IN THE DEVICES MANUFACTURING RECORDS. THE IFU LZA705_EN_V4.3_IFU_CE-MDR CONTAINS THE FOLLOWING NOTES ON PAGE 10 AND 31: 3.8 FAILURE OF PRODUCTS: THE PRODUCT MAY FAIL DURING USE. PERFORM AN EQUIPMENT TEST BEFORE USE, SEE CHAPTER PREPARATION [P. 31]. IF THE IMAGE FAILS DURING THE PROCEDURE, REMOVE THE CAMERA FROM THE ENDOSCOPE AND CONTINUE THE PROCEDURE OPTICALLY. IF THE SURGERY CANNOT BE CONTINUED OPTICALLY, DETERMINATION OF HOW TO FURTHER THE PROCEDURE IS AT THE PHYSICIAN'S DISCRETION BASED ON THE SURGICAL CIRCUMSTANCES. HAVE A REPLACEMENT SYSTEM READY FOR EACH APPLICATION. 5.2 INSPECTING THE PRODUCT: CHECK THE PRODUCT AND THE CAMERA HEAD OR VIDEOENDOSCOPE FOR EXTERNAL DAMAGE. ENSURE THAT THE CAMERA HEAD CABLE OR VIDEOENDOSCOPE CABLE IS NOT DAMAGED OR KINKED. POINT THE CAMERA HEAD OR THE VIDEOENDOSCOPE TOWARD AN OBJECT TO CHECK THE DISPLAY QUALITY ON THE MONITOR. WHEN USING 3D VIDEOENDOSCOPES, CHECK TO MAKE SURE THE MONITOR'S DISPLAY IS CORRECT. BE SURE TO USE THE CORRECT POLARIZED EYEWEAR FOR THE MONITOR. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION "MODULE IS NOT GIVING OUT VIDEO OUTPUT". 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
    1007139 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