BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTUNA

    MDR report key: 25229135 · Received May 20, 2026

    Report

    Report Number
    1216677-2026-00039
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 20, 2026
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    PUB
    UDI-DI
    00888937013856
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: FRANCE. DEVICE IS BEING RETURNED FOR REPAIR. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED TEMPERATURE RAISED ABNORMALLY WITHOUT REASON AND THEY COULD SEE SOME SMOKE COMING FROM THE HG/LS. UNIT TO BE SENT FOR REPAIR. NO HARM REPORTED. NO ADDITIONAL INFORMATION. . WF1200E FORTUNA (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38493 FORTUNA 1200 IVF WORKSTATION PUB COOPERSURGICAL, INC. WF1200E 00888937013856

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown