BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTERA XEO LASER

    MDR report key: 2568631 · Received May 5, 2012

    Report

    Report Number
    MW5025317
    Event Type
    Malfunction
    Date Received
    May 5, 2012
    Report Date
    May 5, 2012
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE IN QUESTION IS A CLASS IV MEDICAL LASER. THE MANUFACTURER, CUTERA, INC., REFUSES TO COMPLY WITH 21 CFR 1040.10-11, SPECIFICALLY, 21 CFR 1040.10-H-2--II--. THE FIRM'S OPERATOR MANUAL FOR THE MODEL (B)(4) AND OTHER XEO LASER PRODUCTS LACKS SERVICE INFORMATION. THOUGH THE FIRM HAS RELEASED ONE VERSION OF THE MANUAL IN THE PAST, THE FIRM HAS UPGRADED THE XEO DEVICE SEVERAL TIMES THROUGHOUT ITS HISTORY. THE PRODUCT HAS BEEN MODIFIED AT LEAST 20 TIMES SINCE 2004, AND FOR EVERY MODIFICATION THERE HAS BEEN A SERVICE SOFTWARE UPGRADE, AND UPDATED SERVICE INFORMATION HAS BEEN DISTRIBUTED TO FIELD SERVICE PERSONNEL, BUT NOT TO PRODUCT USERS, OWNERS, DEALERS, DISTRIBUTORS, AND OTHER SERVICE PERSONNEL WHO MAY REQUEST THIS INFORMATION PURSUANT TO 21 CFR 1040.10-H--2--II-. BECAUSE EACH DEVICE VARIATION REQUIRES A NEW SERVICE SOFTWARE VERSION, THE FIRM IS REQUIRED TO UPDATE ITS SERVICE INFORMATION TO REFLECT THE PROPER USE OF THE NEW SERVICE SOFTWARE. FIRM HAS REFUSED TO RELEASE SERVICE INFORMATION RELATED TO ITS LATEST SERVICE SOFTWARE VERSION, 4.2.7 -OR HIGHER VERSIONS-, AND ALSO REFUSES TO MAKE THIS SOFTWARE AVAILABLE PURSUANT TO THE ABOVE MENTIONED REGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTERA XEO LASER CUTERA XEO COSMETIC LASER SYSTEM GEX CUTERA, INC. US110XEO, US220XEO

    Patients

    Seq Age Sex Outcome Treatment
    1