BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONELIGHT 30

    MDR report key: 5723184 · Received June 14, 2016

    Report

    Report Number
    2951571-2016-00001
    Event Type
    Malfunction
    Date Received
    June 14, 2016
    Date of Event
    March 30, 2015
    Report Date
    June 14, 2016
    Manufacturer
    NEW STAR LASERS, INC. DBA COOLTOUCH INC.
    Product Code
    GEX
    PMA / PMN Number
    K142286
    Removal / Correction Number
    Z-1918-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT PROBLEM REPORTED IN THIS MDR IS ASSOCIATED WITH RECALL Z-1918-2015. ALTHOUGH IT WAS REPORTED TO FDA THROUGH THE FIELD CORRECTIVE ACTION REPORT TO COVER 21 CFR 806 REPORTING REQUIREMENTS, AND MONTHLY FOLLOW-UP STATUS REPORTS, A COMPLAINT WAS NOT OPENED AS THE PRODUCT PROBLEM WAS NOT REPORTED FROM THE FIELD, AND WAS FOUND AT THE MANUFACTURING FACILITY DURING INTERNAL TESTING. HENCE, AN MDR WAS NOT SUBMITTED UNDER 21 CFR 803 REPORTING REQUIREMENTS, AS IT WAS REPORTED THROUGH THE FIELD CORRECTIVE ACTION REPORT. THIS MDR IS NOW BEING SUBMITTED IN ORDER TO MEET REGULATORY REPORTING REQUIREMENTS.

    Description of Event or Problem · 1

    DURING INTERNAL TESTING OF THE STONELIGHT 30 (NS3000) LASER SYSTEM AT THE MANUFACTURING FACILITY, A SITUATION WAS IDENTIFIED THAT COULD OCCUR WHEN CHANGING THE SETTINGS ON THE SYSTEM, WHICH COULD RESULT IN THE NEW SETTING NOT BEING ACCEPTED AND THUS HAS POTENTIAL TO RESULT IN A DISCREPANCY IN THE ENERGY DELIVERED (HIGHER OR LOWER) FROM THE VALUE DISPLAYED ON THE GRAPHICAL USER INTERFACE (GUI) DISPLAY. FOR THIS ISSUE TO MANIFEST, THE FOLLOWING SEQUENCE OF THREE EVENTS MUCH OCCUR IN THIS PRECISE ORDER NEARLY SIMULTANEOUSLY WHILE CHANGING THE SETTINGS ON THE DEVICE: THE LASER IS IN READY MODE AND HAS ALREADY "TEST-FIRED" AT A SETTING, AND THE USER OR OPERATOR TRIES TO CHANGE THE SETTING (POWER, REP RATE, PULSE WIDTH) ON THE LASER SYSTEM, AND USER OR OPERATOR INADVERTENTLY PRESSES DOWN ON THE FOOT SWITCH WITHIN A FRACTION OF A SECOND WITHOUT WAITING FOR THE TEST-FIRE AT THE NEW SETTING. NEW STAR LASERS HAS NOT RECEIVED ANY COMPLAINTS REPORTING OCCURRENCE OF THIS ISSUE IN THE FIELD, AND HAS NOT RECEIVED ANY REPORTS OF INJURY OR DEATH THAT COULD BE LINKED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377240 STONELIGHT 30 POWERED LASER SURGICAL INSTRUMENT GEX NEW STAR LASERS, INC. DBA COOLTOUCH INC. NS3000

    Patients

    Seq Age Sex Outcome Treatment
    1