BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1392631 · Received May 19, 2009

    Report

    Report Number
    1035968-2009-00001
    Event Type
    Other
    Date Received
    May 19, 2009
    Manufacturer
    SUNOPTIC TECHNOLOGIES, LLC
    Product Code
    FSS
    PMA / PMN Number
    K961074
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - BASED ON EXAMINING THE AVAILABLE EVIDENCE, IT SEEMS ALL BUT IMPOSSIBLE THAT THE HEADLIGHT IS RESPONSIBLE FOR THIS BURN BASED ON THE FOLLOWING: FIRST, THE BURNED AREA IS NOT OVER THE SURGICAL SITE. IT SEEMS UNLIKELY IN THE EXTREME THAT A HEADLIGHT, WHOSE SOLE PURPOSE IS TO PROVIDE ILLUMINATION TO THE SURGICAL SITE, WOULD BE TRAINED FOR A SIGNIFICANT AMOUNT OF TIME ON A LOCATION OTHER THAN THE SURGICAL SITE. SECOND, THE EDGES OF THE BURNED AREA ARE REPORTED TO BE VERY SHARPLY DEFINED. THIS IMPLIES THAT THE HEADLIGHT WOULD HAVE BEEN STATIONARY THERE FOR A SIGNIFICANT AMOUNT OF TIME. IT IS UNLIKELY THAT A SURGEON WOULD FOCUS LONG ENOUGH IN ONE SPOT WITHOUT MOVING TO RETRIEVE TOOLS, ETC, THUS ALLOWING SOME COOLING, OR THAT HE WOULD RESETTLE INTO EXACTLY THE SAME SPOT WITH NO VARIATION. THE SIZE OF THE BURN IS SMALLER THAN THE HEADLIGHT'S MAXIMUM DIAMETER AT A WORKING DISTANCE OF 12". IT IS CONSISTENT WITH USE AT A DISTANCE OF 8.5", SIGNIFICANTLY LESS THAN RECOMMENDATIONS. HOWEVER, THE ENERGY IMPARTED BY THE HEADLIGHT DROPS OFF DRAMATICALLY FROM THE CENTER TO THE EDGE OF THE ILLUMINATED SPOT. EVENT IF IT WAS USED AT 8.5", IT APPEARS IMPOSSIBLE FOR A BURN, MUCH LESS A 2ND DEGREE BURN, TO OCCUR WITHIN THE WHOLE OF THE ILLUMINATED AREA. AS THERE IS NOT SUFFICIENT ENERGY IMPARTED IN ALL PARTS OF THE ILLUMINATED SPOT, THERE SHOULD HAVE BEEN AN AREA OF 1ST DEGREE BURN SURROUNDING AN AREA OF 2ND DEGREE BURN. THIS WAS NOT THE REPORTED CASE.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE FSS SUNOPTIC TECHNOLOGIES, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1