BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22472962 · Received July 10, 2025

    Report

    Report Number
    2027009-2025-01203
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 25, 2025
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FET
    PMA / PMN Number
    K131953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 VERIFIED - THE CAMERA WOULD NOT PRODUCE AN IMAGE. A FUNCTIONAL TEST CONFIRMED THE COMPLAINT. TROUBLESHOOTING FOUND A SHORT BETWEEN +12 VOLTS AND GND. SEVERAL COMPONENTS NEEDED TO BE REMOVED TO ISOLATE THE SHORT, WHICH WAS FOUND TO BE C26. AFTER THE REMOVAL OF C26 THE SHORT WAS NO LONGER PRESENT. THE CUSTOMER'S HEADBOARD IS THE ORIGINAL FROM THE 10/12/2016 MANUFACTURE DATE, SO, IT SHOULD BE REPLACED TO ENSURE THERE ARE NO LATENT FAILURES. THE ROOT CAUSE WAS DETERMINED AS +12 VOLTS IS SHORTED TO GND (C26 COMPONENT FAILURE) AND FAILED DUE TO NORMAL WEAR AND TEAR. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "NO IMAGE/BLUE LINES WHEN PLUGGED IN". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120460 ASM,HEAD,IMAGE1 S,H3-Z, CE ASM,HEAD,IMAGE1 S,H3-Z, CE FET KARL STORZ IMAGING TH100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown