BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE MD

    MDR report key: 6301769 · Received February 3, 2017

    Report

    Report Number
    1222993-2017-00009
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    November 19, 2016
    Report Date
    February 3, 2017
    Manufacturer
    CYNOSURE INC
    Product Code
    GEX
    PMA / PMN Number
    K141425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEVELOPED A SUPERFICIAL BURN ON LEG, HOWEVER THIS IS AN EXPECTED SIDE EFFECT FROM LASER TREATMENTS. ALOE VERA GEL WAS GIVEN FOR PREVENTATIVE CARE AS PART OF THE HEALING PROCESS. DEVICE'S YAG WAVELENGTH CHAMBER WAS FOUND TO BE DELIVERING UNSTABLE READINGS/HIGHER ENERGY OUTPUT, SO THE SERVICE TECHNICIAN REPLACED THE AFFECTED CHAMBER AND PERFORMED CALIBRATIONS/ALIGNMENTS. ONCE THE DEVICE WAS REPAIRED, THE LASER SYSTEM WAS THEN FOUND OPERATING AS INTENDED. THIS IS REPORTABLE BECAUSE THE DEVICE MALFUNCTIONED AND REQUIRED SYSTEM REPAIRS TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    DEVICE USED IN LASER PROCEDURE WAS FOUND NOT OPERATING AS INTENDED, RESULTING IN PATIENT BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84733 ELITE MD ELITE MD GEX CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other