BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRAC VELOCITY AL 10000

    MDR report key: 5084101 · Received September 15, 2015

    Report

    Report Number
    2031934-2015-00009
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    August 21, 2015
    Report Date
    September 10, 2015
    Manufacturer
    PHOTO MEDEX, INC.
    Product Code
    GEX
    PMA / PMN Number
    K073695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED UPON EVALUATION OF THE RETURNED HANDPIECE (SERIAL NUMBER (B)(4)) WHERE CUSTOMER STATED "INCORRECT AND INADVERTENT OPERATION" THAT MOST LIKELY INCONSISTENCIES DURING THE ASSEMBLY PROCESS AND EXCESSIVE USER FORCE WERE THE CAUSES OF THE EVENT. TWO POTENTIAL CAUSES WERE FOUND TO BE LIKELY CONTRIBUTING TO THE EVENT EXPERIENCED BY THE USER: A BROKEN WIRE AND A SMALL CUT IN THE TRIGGER WIRE ALONG WITH DAMAGED GROUND BRAID. CAUSE: THE BROKEN WIRE: LIKELY CONTRIBUTORS FOUND TO BE A USER ERROR THAT COULD HAVE EXERTED EXCESSIVE FORCE DURING REMOVAL OF THE PLUG FROM THE DEVICE; ADDITIONALLY, THE PROTECTIVE PLUS HOUSING WAS LOOSE, BECAUSE LACK OF ADHESIVE AND/OR WORN THREADS. CAUSE: TRIGGER WIRE SMALL CUT AND DAMAGED GROUND BRAID: LIKELY CONTRIBUTORS FOUND TO BE THE USER THAT COULD HAVE EXERTED INAPPROPRIATE TWISTING OF THE CABLE; ADDITIONALLY, THE SMALL CUT IN THE TRIGGER WIRE THAT WAS ACCIDENTALLY INFLICTED DURING THE STRIPPING OF THE WIRE.

    Description of Event or Problem · 1

    ON (B)(6) 2015 IT WAS REPORTED TO PHOTOMEDEX FROM DR. (B)(6) OFFICE, (B)(6) STATED THAT THE CORD OF THE HANDPIECE WAS TWISTED AND THE HANDPIECE MUST BE HELD ON A CERTAIN POSITION TO OPERATE AS INTENDED. CUSTOMER FELT THAT THE HANDPIECE WAS NOT OPERATING CORRECTLY AND OPERATING UNINTENDEDLY. LATER ON (B)(6) 2015, (B)(6) (SERVICE MANAGER) CONTACTED (B)(6) AT DR. (B)(6) OFFICE, WHO EXPLAINED THAT WHEN THE DEVICE IS IN READY MODE THE HANDPIECE (IN A CERTAIN POSITION) WILL OPERATE UNINTENDEDLY AND THE HANDPIECE WILL NOT OPERATE AS INTENDED. HANDPIECE SERIAL NUMBER (B)(4) AS OF 09/10/2015 HAS BEEN DETERMINED TO BE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609717 XTRAC VELOCITY AL 10000 GEX PHOTO MEDEX, INC. V400

    Patients

    Seq Age Sex Outcome Treatment
    1