BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMAGE1S 4U RUBINA, OPAL1 NIR/ICG

    MDR report key: 22482863 · Received July 11, 2025

    Report

    Report Number
    2027009-2025-01211
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 20, 2025
    Report Date
    March 10, 2026
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    OWN
    UDI-DI
    04048551430569
    PMA / PMN Number
    K201399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE INVOLVED PRODUCTS WERE RETURNED TO THE KARL STORZ SUBSIDIARY IN INDIA. DURING INSPECTION OF THE PRODUCTS THE ERROR REPORTED BY THE CUSTOMER COULD NOT BE REPRODUCED. HOWEVER, IT WAS DETECTED THAT THE RECEPTACLE/ CONNECTOR SOCKET FOR THE CAMERA HEAD CABLE IN THE TC304 LINK SHOWS SIGNS OF DEPOSITION AND CORROSION. IT IS CONCLUDED THAT THIS WAS THE CAUSE OF THE REPORTED ISSUE. THE OTHER PRODUCTS INVOLVED (TC201 & TH121) WERE ALSO INSPECTED, BUT NO RELEVANT ISSUES/ DEFECTS CORRESPONDING TO THE CUSTOMERS' ERROR DESCRIPTION WERE FOUND. THE INVESTIGATIONS DID NOT REVEAL A ROOT CAUSE RELATED TO THE LABELLING, THE DEVICE, OR ITS HISTORY. ALL PRODUCTION-RELATED QUALITY CHECKS WERE PASSED, AND NO NON-CONFORMITIES WERE IDENTIFIED IN THE DEVICE'S MANUFACTURING RECORDS. IN ADDITION, WE WOULD LIKE TO CALL YOUR ATTENTION TO THE FOLLOWING INFORMATION STATED IN THE INSTRUCTIONS FOR USE (IMAGE1 S - DOCUMENT: LZA705_EN_V4.3_07-2024_IFU_CE-MDR). PAGE 10: "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." PAGE 31: "5.2 INSPECTING THE PRODUCT: 1.CHECK THE PRODUCT AND THE CAMERA HEAD OR VIDEOENDOSCOPE FOR EXTERNAL DAMAGE. 2.ENSURE THAT THE CAMERA HEAD CABLE OR VIDEOENDOSCOPE CABLE IS NOT DAMAGED OR KINKED. 3.POINT THE CAMERA HEAD OR THE VIDEOENDOSCOPE TOWARD AN OBJECT TO CHECK THE DISPLAY QUALITY ON THE MONITOR. 4.WHEN USING 3D VIDEOENDOSCOPES, CHECK TO MAKE SURE THE MONITOR'S DISPLAY IS CORRECT. 5.BE SURE TO USE THE CORRECT POLARIZED EYEWEAR FOR THE MONITOR." THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    INFORMATION WAS RECEIVED THAT THE PRODUCT WILL NOT BE RETURNED TO THE MANUFACTURER." THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "UNIT BLANKS OUT AND IMAGE FLICKERING OCCURRED". IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT, USER OR THIRD PARTY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDRS: 9610617-2025-01210, 9610617-2025-01212.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385157 IMAGE1S 4U RUBINA, OPAL1 NIR/ICG IMAGE1S 4U RUBINA, OPAL1 NIR/ICG OWN KARL STORZ IMAGING TH121 04048551430569

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown