BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS PULSE 100H

    MDR report key: 10477281 · Received September 1, 2020

    Report

    Report Number
    10477281
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    July 30, 2020
    Report Date
    August 5, 2020
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 0

    THE NEW LASER MACHINE LUMENIS CONTINUES TO SHUT DOWN IN THE MIDDLE OF SURGERY. NO ERROR MESSAGES OR ANY ALARM OR SOUND, THE UNIT WILL STOP WORKING AND SHUTDOWN AS SOON AS WE CONNECT LASER FIBER TO THE UNIT. NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    THE NEW LASER MACHINE LUMENIS CONTINUES TO SHUT DOWN IN THE MIDDLE OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944739 LUMENIS PULSE 100H POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS, INC. LUMENIS PULSE 100H

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA