BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASM,HEAD,IMAGE1 S,H3-ZA, CE

    MDR report key: 23853578 · Received December 19, 2025

    Report

    Report Number
    2027009-2025-02379
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    June 3, 2025
    Report Date
    January 16, 2026
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FET
    UDI-DI
    04048551333969
    PMA / PMN Number
    K131953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE COMPLAINT ISSUE WAS DESCRIBED AS TURNED ON AND GOT AN IMAGE, THEN SQUIGGLY LINES AND THEN A BLACK SCREEN. THE CUSTOMER'S COMPLAINT WAS VERIFIED. DURING THE SERVICE PROCESS, IT WAS DETERMINED THAT THE CUSTOMER'S REASON FOR RETURN WAS CAUSED BY A DEFECTIVE CABLE. THE CUSTOMER CABLE WAS JUST PREVIOUSLY REPLACED ON (B)(6) 2025 FOR CARD EDGE CONTAMINATION. IT'S HIGHLY RECOMMENDED THAT THE CUSTOMER REVIEWS THEIR HANDLING/STERILIZATION METHODS TO ENSURE THEY ARE FOLLOWING APPROVED KARL STORZ PROTOCOLS. ALSO, THE CUSTOMER CCU RECEPTACLE SHOULD BE EVALUATED FOR CORRESPONDING CONTAMINATION THAT COULD ALSO CAUSE FUTURE IMAGE STABILITY ISSUES OR ACCELERATED WEAR ON THE NEWLY REPLACED CAMERA CABLE CARD EDGE. REPLACING THE CABLE SHOULD ADDRESS THE CUSTOMER'S REASON FOR RETURN. THE CAUSE OF THE ISSUE WAS DETERMINED AS DEFECTIVE CABLE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE CUSTOMER TRIED TO TURN ON THE UNIT THAT CAME FROM THE REPAIR AND GOT A BLACK SCREEN". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251912 ASM,HEAD,IMAGE1 S,H3-ZA, CE ASM,HEAD,IMAGE1 S,H3-ZA, CE FET KARL STORZ IMAGING TH104 04048551333969

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown