BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINEVO 900

    MDR report key: 22795061 · Received August 13, 2025

    Report

    Report Number
    9615010-2025-00018
    Event Type
    Death
    Date Received
    August 13, 2025
    Date of Event
    July 15, 2025
    Report Date
    August 13, 2025
    Manufacturer
    CARL ZEISS MEDITEC AG (OBERKOCHEN)
    Product Code
    FSO
    UDI-DI
    04049539066404
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE ITSELF AS WELL AS THE LOGFILES WERE EVALUATED AND THERE IS NO INDICATION THAT THERE WAS A MALFUNCTION OF THE OPMI KINEVO 900 THAT COULD HAVE CONTRIBUTED TO THE FOCUSING PROBLEMS AND COMPLICATIONS DURING SURGERY. THERE SEEMS TO BE NO INDICATION THAT REASONABLY SUGGESTS THAT THE DEVICE HAS CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH OR THAT A MALFUNCTION OF THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT.

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE OPMI KINEVO 900 STOPPED FOCUSING DURING A BRAIN OPERATION AFTER BLEEDING OF THE BRAIN HAD STARTED. IT WAS FURTHER REPORTED, THAT THE PATIENT LOST 7 LITERS OF BLOOD. THE DEVICE WAS WORKING WITHOUT ANY ISSUES UPON INSPECTION; NO FURTHER REPORTED ISSUES AFTER THE INCIDENT. THE SURGEON NOTED THAT THE BLEEDING OCCURRED BEFORE THE ASSUMED ISSUE WITH THE FOCUS. THE HEMORRHAGE WAS UNDER CONTROL BEFORE THE LOSS OF FOCUS AND RESTART OF THE DEVICE. NO HARM WAS REPORTED DIRECTLY FROM THE INCIDENT. THE DEVICE PROBLEM WAS RESOLVED BY SHUTTING DOWN AND RESTARTING THE MICROSCOPE. THE PATIENT DIED THREE DAYS AFTER SURGERY. THE REASON FOR THE DEATH REMAINS UNKNOWN TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814626 KINEVO 900 MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY FSO CARL ZEISS MEDITEC AG (OBERKOCHEN) 900 04049539066404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death