BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLEMAX PRO

    MDR report key: 3880196 · Received April 9, 2014

    Report

    Report Number
    1218402-2014-00010
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 9, 2014
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    PMA / PMN Number
    K133283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS INSTALLED AT THE USER SITE NOVEMBER 21, 2012. THERE HAVE BEEN NO CLINICAL COMPLAINTS FROM THE USER SITE REGARDING THIS SPECIFIC SERIAL NUMBER SINCE THAT TIME. THE PRODUCT DEVICE HISTORY RECORD AND SERVICE HISTORY WAS REVIEWED (B)(4) 2014 WITH NO ISSUES FOUND. A CANDELA FIELD SERVICE ENGINEER INSPECTED THE SYSTEM AND REPORTED THAT THE BEAM BLOCKER WAS FOUND TO BE BROKEN. THE FIELD SERVICE ENGINEER REPLACED THE BEAM BLOCKER AND CONFIRMED THAT THE BEAM BLOCKER WAS OPERATING PROPERLY. THE LASER IS NOW OPERATING PER CANDELA SPECS. IT IS BELIEVED THAT A BROKEN PIECE FROM THE BEAM BLOCKER MAY HAVE CONTRIBUTED TO THE NOISE FROM THE SYSTEM.

    Description of Event or Problem · 1

    A SITE REPORTED THAT THEY HEARD A CLUNKY NOISE WHEN THE LASER WAS CALIBRATING AND NOTICED A BLEEDER PULSE ALLOWING ENERGY TO PASS THROUGH THE FIBER. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213352 GENTLEMAX PRO DERMATOLOGY LASER GEX CANDELA CORP. 9914-00-9035 NA

    Patients

    Seq Age Sex Outcome Treatment
    1