BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM

    MDR report key: 4013969 · Received July 3, 2014

    Report

    Report Number
    1222993-2014-00024
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 3, 2014
    Report Date
    July 1, 2014
    Product Code
    GEX
    PMA / PMN Number
    K050382
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LASER ENERGY IS OUT OF CYNOSURE SPECIFICATION AND THE ENERGY IS 20% LESS THAN NOMINAL. CUSTOMER IS AWARE THAT THE FLASH LAMP NEEDS TO BE REPLACED AND HAS BEEN ADVISED OF THE RISK AND HAS DECLINED TO CHANGE THE LAMP.

    Description of Event or Problem · 1

    THE LASER ENERGY IS OUT OF CYNOSURE SPECIFICATION AND IT IS LESS THAN 20% BELOW NOMINAL. NO PATIENT INJURY IS ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392102 AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM AFFINITY QS Q-SWITCHED ND:YAG LASER GEX

    Patients

    Seq Age Sex Outcome Treatment
    1