BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTA DUET

    MDR report key: 1746310 · Received June 30, 2010

    Report

    Report Number
    2914019-2010-00031
    Event Type
    Injury
    Date Received
    June 30, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 30, 2010
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K081704
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE REPORTED EVENT DETAILS, CONDUCTED BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT, CONCLUDED ROOT-CAUSE TO BE DEVICE OPERATOR FAILURE TO DETERMINE THE TREATMENT MODE OF THE SUBJECT DEVICE PRIOR TO USE. MODE MIS-SELECTION LED TO FOVEAL BURN WITHIN THE PATIENT'S EYE. WITHIN THE SYSTEM DESIGN, THE REMOTE DISPLAY CLEARLY SHOWS THE ACTIVE TREATMENT MODE TO THE USER, WITH DIRECT IDENTIFICATION OF SET OPERATING MODE (I.E. SLT VS. ND:YAG). NO REPORT OF DEVICE MALFUNCTION WAS RECEIVED THEREFORE, NO EVALUATION OF THE SUBJECT DEVICE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPHTHALMIC SURGICAL PROCEDURE, THE PHYSICIAN ASSUMED THEY WERE USING THE YAG MODE OF THE SELECTA DUET LASER WHEN IN FACT THE LASER WAS SET TO SLT MODE. IT WAS FURTHER REPORTED, THE PATIENT SUSTAINED A FOVEAL BURN AND LOSS OF VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTA DUET ND:YAG SURGICAL LASER GEX LUMENIS, INC. DUET NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability