BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICOSURE WORKSTATION

    MDR report key: 4152308 · Received October 3, 2014

    Report

    Report Number
    1222993-2014-00033
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 3, 2014
    Report Date
    October 1, 2014
    Product Code
    GEX
    PMA / PMN Number
    K140719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL WAS PERFORMED AND THE CYNOSURE SERVICE ENGINEER FOUND THAT THE SHUTTER ON THE HANDPIECE HAD A LOOSE SCREW. THE SCREW WAS TIGHTENED AND THE LASER PERFORMED TO SPECIFICATION. THIS IS AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    LASER FIRING ON ITS OWN. NO PATIENTS WERE INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617271 PICOSURE WORKSTATION PICOSURE WORKSTATION GEX

    Patients

    Seq Age Sex Outcome Treatment
    1