BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRAC VELOCITY AL 10000

    MDR report key: 5022521 · Received August 21, 2015

    Report

    Report Number
    2031934-2015-00005
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    April 2, 2012
    Report Date
    August 18, 2015
    Manufacturer
    PHOTO MEDEX, INC.
    Product Code
    GEX
    PMA / PMN Number
    K073695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED DURING EVAL ((B)(6) 2012) THAT THE DEVICE CONTROL SWITCH WAS OPERATING IN ACCORDANCE WITH SPECIFICATIONS, CUSTOMER ALLEGATIONS WERE TRIED TO DUPLICATED BUT FOUND THAT UNIT PERFORMED ACCORDING TO SPECIFICATIONS. AT THE TIME OF THE EVAL, NO CAUSE OF FAILURE WAS FOUND. UPON INITIAL REVIEW OF THIS INCIDENT, IT DID NOT APPEAR TO BE A REPORTABLE INCIDENT, FURTHER REVIEW AND DISCUSSION WITH THE USER ((B)(6) 2015), IT WAS DETERMINED NECESSARY TO REPORT THIS INCIDENT DUE TO THE DETAILS SUGGEST THAT THE DEVICE SWITCH CONTROL WOULD BE LIKELY TO CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR; THIS EXPLAINS THE TIME LAG IN REPORTING.

    Description of Event or Problem · 1

    ON (B)(6) 2012 IT WAS REPORTED TO PHOTOMEDEX BY SKIN CARE DOCTORS/(B)(6), THAT THE DEVICE USER WAS HAVING ISSUES WITH THE CONTROL SWITCH OF THE DEVICE, WHICH WAS NOT WORKING AS EXPECTED- OPERATING UNINTENDEDLY, SERIAL NUMBER (B)(4). PHOTOMEDEX SERVICE SENT OUT A REPLACEMENT CONTROL SWITCH TO THE USER RIGHT AFTER TO REMOVE THE CONTROL SWITCH PRESENTING ISSUES. FURTHER ATTEMPT WAS MADE ON (B)(6) 2015 BY PHOTOMEDEX TO GATHER FURTHER DETAILS WITH THE DEVICE USER TO CONFIRM UNINTENDED OPERATION OF THE CONTROL SWITCH. DMA (LP) AT THE CLINIC CONFIRMED THAT THE CONTROL SWITCH WAS NOT FULLY RELEASED WHEN THE USER REMOVED THE FINGER, THUS MAY KEPT OPERATING UNINTENDEDLY FOR FRACTIONS OF A SECOND, UNTIL FULL STOP. AS OF (B)(6) 2015 HAS BEEN DETERMINED TO BE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555609 XTRAC VELOCITY AL 10000 EXCIMER LASER GEX PHOTO MEDEX, INC. V700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention