BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCU,MODULAR,4U-LINK,US

    MDR report key: 21559564 · Received March 10, 2025

    Report

    Report Number
    2027009-2025-00375
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Report Date
    April 2, 2025
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FET
    PMA / PMN Number
    K160044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURING SITE. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    PER EVALUATION FROM THE MANUFACTURER: COMPLAINT VERIFIED - INTERMITTENT IMAGE ISSUES WERE ENCOUNTERED WHEN THE CARD EDGE WAS MANIPULATED. A FUNCTIONAL TEST CONFIRMED THE COMPLAINT. TROUBLESHOOTING FOUND THAT THE SAMTEC CONNECTOR GOLD WAS WORN TO THE POINT THAT COPPER AND NICKEL WERE EXPOSED. THE CCU IS APPROACHING 6 YEARS OLD AND THE CUSTOMER'S COMPLAINT WAS CAUSED BY NORMAL WEAR AND TEAR. THE SAMTEC CONNECTOR CAN'T BE REPLACED AT KSI, SO A MOTHERBOARD REPLACEMENT IS MANDATORY. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE THE COLORS WENT FUNNY GREEN, PURPLE AND LOST IMAGE. IT WAS CONFIRMED THAT THERE WAS NO INJURY/ IMPACT TO THE PATIENT DUE TO THIS AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE USING A BACK-UP MOBILE TOWER WITH A DELAY OF ROUGHLY 10 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144422 CCU,MODULAR,4U-LINK,US CCU,MODULAR,4U-LINK,US FET KARL STORZ IMAGING TC304US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown