BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPMI LUMERA 700

    MDR report key: 21387786 · Received February 14, 2025

    Report

    Report Number
    9615010-2025-00002
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 15, 2025
    Report Date
    February 14, 2025
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA) OKO
    Product Code
    FSO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL CASE, A MECHANISM DETACHED DUE TO A LOOSE SCREW, CAUSING THE OPMI HEAD OF A LUMERA 700 TO HANG LOOSELY AT A 90 DEGREE ANGLE, ALMOST HITTING THE PATIENT IN THE FACE. THE USER MOVED THE PATIENT TO ANOTHER OPERATING ROOM AND COMPLETED THE CASE. THERE WAS NO INJURY OR NEGATIVE IMPACT TO A PATIENT, USER OR A THIRD PARTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002453 OPMI LUMERA 700 OPMI LUMERA 700 FSO CARL ZEISS MEDITEC AG (JENA) OKO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown