BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMAGE1 S HX-P FI

    MDR report key: 21470298 · Received February 26, 2025

    Report

    Report Number
    2027009-2025-00318
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    February 7, 2025
    Report Date
    April 28, 2025
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FET
    PMA / PMN Number
    K160044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTION D9 TO REFLECT THAT THE PRODUCT WAS RETURNED FOR EVALUATION. THE INVESTIGATION IS NOT COMPLETED YET. THE INVESTIGATION RESULTS ARE PENDING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE IN QUESTION WAS RETURNED BY THE CUSTOMER ON FEBRUARY 26,2025 AND THE INVESTIGATION WAS COMPLETED ON APRIL 24,2025. DURING THE MANUFACTURER'S TECHNICAL INSPECTION, THE ERROR DESCRIPTION PROVIDED BY THE CUSTOMER "PENDULUM HEAD IS NOT WORKING WELL, IT GETS FOGGY " WAS CONFIRMED. FURTHER DEFECTS WERE DETECTED AS WELL WHILE INSPECTION. THESE DEFECTS HAD NO INFLUENCE ON THE REPORTED ISSUE, IT IS MORE A SUBSEQUENT FAULT OF THE LEAKAGE. THE SOFTWARE WAS UP TO DATE. BASED ON THE DEFECTS FOUND DURING THE TECHNICAL INSPECTION IT IS CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DESCRIBED ERROR IS A DEFECT SEALING ON THE FOCUS WHEEL DUE TO WEAR. CONSEQUENTLY, LIQUID CAN ENTER THE CAMERA HEAD DURING REPROCESSING. THE MOISTURE IN THE CAMERA HEAD CAUSES THE LENSES TO FOG UP WHEN THE PRODUCT HEATS UP, WHICH IN TURN LEADS TO A BLURRY LIVE IMAGE. THE IFU IS STATING THIS "FAILURE OF PRODUCTS" CLEARLY. THE ABOVE 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. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE PENDULUM HEAD IS NOT WORKING WELL, IT GETS FOGGY, AND THEY CAN'T OPERATE PROPERLY. THE MEDICAL PROCESS ENDED SATISFACTORILY BUT BECAUSE THEY CHANGED THEIR EQUIPMENT. THE EXACT TIME OF PROLONGATION IS 60 MINUTES". THEREFORE, A REPORT IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340633 IMAGE1 S HX-P FI ENDOSCOPE VIDEO CAMERA FET KARL STORZ IMAGING TH113

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other