BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCU,MODULAR,IMAGE1 S X-LINK,US

    MDR report key: 22472982 · Received July 10, 2025

    Report

    Report Number
    2027009-2025-01201
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Report Date
    July 25, 2025
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FET
    UDI-DI
    04048551356562
    PMA / PMN Number
    K160044
    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 - INTERMITTENT IMAGE DROP. A FUNCTIONAL TEST CONFIRMED THE CUSTOMER'S COMPLAINT. MANIPULATING THE IML CONNECTOR COULD INDUCE THE INTERMITTENT IMAGE DROP FAILURE. A VISUAL INSPECTION WAS UNABLE TO IDENTIFY ANY OBVIOUS ISSUES WITH THE IML CONNECTOR. CLEANING THE CONNECTOR DID NOT RESOLVE THE ISSUE. THE ISSUE OCCURRED WITH MULTIPLE IML TEST FIXTURE CABLES, INDICATING THE ISSUE RESIDES WITH THE MOTHERBOARD CONNECTION. THE IML CONNECTOR CAN'T BE REPLACED AT KARL STORZ - GOLETA, SO A MOTHERBOARD REPLACEMENT WILL BE REQUIRED. THE CCU IS OVER 6 YEARS OLD, AND THE CONNECTOR HAS BECOME INTERMITTENT DUE TO NORMAL WEAR AND TEAR. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE INFORMATION RECEIVED, THE DEVICE GIVING ISSUES WITH IMAGE OUTPUT EXPERIENCING STATICY IMAGE AND SOMETIMES GOES BLANK. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046300 CCU,MODULAR,IMAGE1 S X-LINK,US CCU,MODULAR,IMAGE1 S X-LINK,US FET KARL STORZ IMAGING TC301US 04048551356562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown