BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLUOPTICS FLUOBEAM®¿LX

    MDR report key: 25103717 · Received May 6, 2026

    Report

    Report Number
    MW5187819
    Event Type
    Other
    Date Received
    May 6, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 4, 2026
    Manufacturer
    FLUOPTICS SAS
    Product Code
    QDG
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FLUOPTICS FLUOBEAM® LX USED FOR ENDOCRINE SURGERY. CAMERA CREATED A HOLE IN OR DRAPES WITH INFRARED LIGHT. NO INFORMATION IN THE INSTRUCTIONS OR MANUAL ABOUT POTENTIAL FOR INFRARED LIGHT TO BURN THROUGH DRAPES QUICKLY RESULTING IN A POTENTIAL BREAK IN STERILITY. ONLY INFORMATION RELATED TO NOT POINTING THE LIGHT INTO EYES. NO PATIENT OR CAREGIVER HARM RESULTED FROM OR DRAPE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489728 FLUOPTICS FLUOBEAM®¿LX PARATHYROID AUTOFLUORESCENCE IMAGING DEVICE QDG FLUOPTICS SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown