BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTMAT ULTRA-THIN FLEXIBLE SURGICAL ILLUMINATOR

    MDR report key: 1073982 · Received July 3, 2008

    Report

    Report Number
    1528108-2008-00001
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    April 28, 2008
    Report Date
    July 4, 2008
    Manufacturer
    LUMITEX
    Product Code
    HJN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIOUSNESS OF THE INJURY IS MINOR, DESCRIBED BY THE HOSPITAL AS 3 SMALL BURNS, DESPITE SEVERAL ATTEMPTS BY LUMITEX MD, INC. TO ASCERTAIN OTHER DETAILS, WE COULD NOT LEARN OTHER DETAILS ABOUT THE INJURIES. THE HOSPITAL INVESTIGATION DETERMINED THAT THE HOSPITAL PLUGGED THE LIGHT SOURCE INTO A LIGHT SOURCE CABLE THAT DID NOT MEET SPECIFICATIONS. A 5MM LIGHT SOURCE CABLE WAS USED INSTEAD OF THE SPECIFIED 4MM CABLE. USE OF A CABLE LARGER IN DIAMETER THAN 4MM CAN RESULT IN OVERHEATING. THE POTENTIAL FOR PATIENT INJURY RESULTING FROM OVERHEATING IS DOCUMENTED IN THE LIGHTMAT SURGICAL ILLUMINATOR LABELING. THE INSTRUCTIONS FOR USE CONTAIN A WARNING STATING "DO NOT USE LIGHT SOURCES RATED HIGHER THAN 300 WATTS, OR CABLES WITH FIBER OPTIC BUNDLES OF MORE THAN 4MM DIAMETER. USE OF HIGHER WATT SOURCES OR LARGER DIAMETER CABLES COULD RESULT IN OVERHEATING, CAUSING PRODUCT FAILURE AND PATIENT INJURY." IN THIS CASE, THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED. IN RESPONSE TO THIS EVENT, THE LOCAL SALES REPRESENTATIVE FOR LUMITEX MD, PROVIDED RE-TRAINING TO THE HOSPITAL STAFF ON JUNE 6, ON THE USE OF THE LIGHTMAT PRODUCT. ALSO, THE HOSPITAL SUGGESTED THAT LUMITEX RE-EVALUATE THE CABLE DESIGN TO PREVENT ALTERNATE CABLE COMPATIBILITY. MANY CUSTOMERS PREFER A STANDARD CABLE, AS DESIGNED, SO THEY CAN USE EXISTING HOSPITAL CABLES AND NOT REQUIRE CUSTOM PURCHASES. BECAUSE THE HEATING ISSUE IS COVERED IN THE IFU, AND BECAUSE WE BELIEVE THIS IS AN ISOLATED INCIDENT, LUMITEX WILL MAINTAIN THE CURRENT DESIGN.

    Description of Event or Problem · 1

    THE LIGHTMAT ULTRA-THIN FLEXIBLE SURGICAL ILLUMINATOR WAS USED FOR VISUAL CLARITY WHEN WORKING IN THE BREAST POCKETS OF A PATIENT UNDERGOING A DOUBLE MASTECTOMY. WHEN THE DRAPES WERE PULLED BACK FOR REPOSITIONING, THE PATIENT WAS NOTED TO HAVE THREE SMALL BURNS. THE HOSPITAL REPORTED THAT THE BURNS WERE A RESULT OF THE LIGHTMAT ULTRA-THIN FLEXIBLE SURGICAL ILLUMINATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTMAT ULTRA-THIN FLEXIBLE SURGICAL ILLUMINATOR LIGHTMAT SURGICAL ILLUMINATOR HJN LUMITEX UA2550 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other