BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS MOSES 200 B/F/L

    MDR report key: 12689327 · Received October 22, 2021

    Report

    Report Number
    MW5104920
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    October 13, 2021
    Report Date
    October 20, 2021
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRODUCT USED DURING PROCEDURE AND WAS DEFECTED. PRODUCT WAS USED ON PATIENT ON (B)(6) 2021 AND WAS DEFECTIVE. THERE WAS NO HARM EVIDENT TO THE PATIENT. DR. (B)(6) OPENED A NEW PRODUCT AND PROCEEDED WITH PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576394 LUMENIS MOSES 200 B/F/L POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS, INC. AC-10030100 75770621

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR