BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONATA SYSTEM LASER (MYTHOS 500)

    MDR report key: 599346 · Received June 21, 2004

    Report

    Report Number
    3004167969-2004-00001
    Event Type
    Malfunction
    Date Received
    June 21, 2004
    Date of Event
    April 21, 2004
    Report Date
    June 18, 2004
    Manufacturer
    MSQ (M2) LTD.
    Product Code
    GEX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 2004 HEALTH CARE PROFESSIONAL REPORTED THAT A SONATEA LASER SYSTEM MALFUNCTIONED AND 'CAUGHT ON FIRE WITHOUT HUMAN INVOLVEMENT'. IN WRITTEN CORRESPONDENCE DATED 06/2004 HEALTHCARE PROFESSIONAL REPORTED THAT UNIDENTIFIED PERSONNEL EXPERIENCED SIDE EFFECTS (UNSPECIFIED) FROM THE FIRE, THE PHYSICIAN-USER REPORTED NAUSEA AND VOMITING DUE TO FIRE EXTINGUISHER USE, AND THAT THE HEALTHCARE STAFF WERE `TRAUMATIZED' (UNSPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONATA SYSTEM LASER (MYTHOS 500) SURGICAL LASER GEX MSQ (M2) LTD. SONATA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other