BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTA DUET

    MDR report key: 12040406 · Received June 22, 2021

    Report

    Report Number
    12040406
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 25, 2021
    Report Date
    June 16, 2021
    Manufacturer
    LUMENIS INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER THE SURGEON STARTED TO USE THE YAG ((YTTRIUM-ALUMINUM-GARNET) LASER TO THE PATIENT'S RIGHT EYE. THE LASER WAS IDENTIFIED TO NOT BE WORKING. PROCEDURE WAS INCOMPLETE DUE TO LASER NOT WORKING. PATIENT HAD TO RE-SCHEDULE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941249 SELECTA DUET POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS INC. SELECTA DUET

    Patients

    Seq Age Sex Outcome Treatment
    1