BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCOPEYE

    MDR report key: 25173463 · Received May 13, 2026

    Report

    Report Number
    MW5188235
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Report Date
    May 11, 2026
    Manufacturer
    MEDITHINQ CO., LTD.
    Product Code
    FEM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) (CC) CALLED TO REPORT THAT DURING SURGERY, THE SCOPEYE WENT UNRESPONSIVE. THE SURGEON STATED THAT THE HEADSET STAYED UNRESPONSIVE FOR AROUND 30 SECONDS, WHILE THE STEALTH SCREEN WAS NAVIGATING AS EXPECTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254425 SCOPEYE ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) FEM MEDITHINQ CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown