BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPUS SYSTEM

    MDR report key: 25151394 · Received May 12, 2026

    Report

    Report Number
    3004450661-2026-00009
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ALMA LASERS LTD.
    Product Code
    GEI
    UDI-DI
    17290110121782
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT A PATIENT SUSTAINED A BURN AT THE TREATMENT SITE FOLLOWING USE OF THE OPUS SYSTEM. ALMA LASERS INC. CONDUCTED AN INVESTIGATION AND DETERMINED THAT THE EVENT WAS MOST LIKELY ATTRIBUTABLE TO USER TECHNIQUE. HOWEVER, AS THE INJURY IS EXPECTED TO RESULT IN SCARRING, THIS EVENT IS BEING REPORTED IN GOOD FAITH. THE DEVICE WAS REQUESTED FOR EVALUATION; HOWEVER, DESPITE MULTIPLE DUE DILIGENCE ATTEMPTS BY ALMA LASERS INC. TO COORDINATE DEVICE RETRIEVAL, THE CUSTOMER HAS NOT RESPONDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525895 OPUS SYSTEM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ALMA LASERS LTD. 1 17290110121782

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other