BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22472984 · Received July 10, 2025

    Report

    Report Number
    2027009-2025-01204
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 2, 2025
    Report Date
    September 16, 2025
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FET
    UDI-DI
    04048551333969
    PMA / PMN Number
    K131953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION WAS RETURNED 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

    DEVICE EVALUATION: COMPLAINT NOT VERIFIED - THE CAMERA WAS TESTED OVER MULTIPLE DAYS, BUT NO IMAGE ISSUES WERE DETECTED. KSUS GOLETA SERVICE INCOMING WAS UNABLE TO DUPLICATE THE CUSTOMER'S ISSUE. KSUS GOLETA PROCESS ENGINEERING TESTED THE CAMERA FOR OVER A WEEK WITHOUT ISSUE. A VISUAL INSPECTION WAS UNABLE TO IDENTIFY ANY ISSUES. FUNCTIONAL TESTING INCLUDED SEVERAL OVERNIGHT BURN-IN SESSIONS. THE CAMERA WAS TESTED FOR OVER A WEEK AND IT NEVER FAILED TO PRODUCE A QUALITY IMAGE CONSISTENT WITH OTHER KNOWN WORKING TH104 CAMERA HEADS. UNABLE TO DUPLICATE THE CUSTOMER'S REPORTED COMPLAINT. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION WHEN TRYING TO USE CAMERA HEAD CAN'T SEE IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046302 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