BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTARO 300

    MDR report key: 24356181 · Received February 16, 2026

    Report

    Report Number
    3008564898-2026-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    January 23, 2026
    Report Date
    February 16, 2026
    Manufacturer
    CARL ZEISS MEDITEC (SUZHOU) CO., LTD.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MOST POSSIBLE ROOT CAUSE IS THAT THE SCREW WAS INTENTIONALLY UNSCREWED, WHICH LED TO THE CONNECTION ISSUE BETWEEN THE OPMI AND MORA IN THIS INCIDENT.

    Description of Event or Problem · 0

    THE BODY OF THE HEAD BECAME DETACHED FROM THE MORA ADAPTER AND, CONSEQUENTLY, FROM THE SUSPENSION ARM. THE SURGEON SCREWED IT BACK IN AND IS USING THE EQUIPMENT NOW. NO HARM WAS CAUSED TO THE PATIENT AS THE SURGEON SUPPORTED THE HEAD WHEN IT DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421164 EXTARO 300 MICROSCOPE, SURGICAL EPT CARL ZEISS MEDITEC (SUZHOU) CO., LTD. 300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown