BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTMAT SURGICAL ILLUMINATOR

    MDR report key: 4687259 · Received April 7, 2015

    Report

    Report Number
    1528108-2015-00001
    Event Type
    Injury
    Date Received
    April 7, 2015
    Date of Event
    February 11, 2014
    Report Date
    March 10, 2015
    Manufacturer
    LUMITEX, INC.
    Product Code
    HJN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS FIRST REPORTED TO LUMITEX ON (B)(4) 2014 VIA A PHONE CALL FROM COMPLAINANT (B)(6) FROM THE (B)(6). (B)(6), A CLINICAL ENGINEER, LEFT A VOICE MAIL WITH (B)(4), LUMITEX QUALITY DIRECTOR. (B)(4) WROTE THAT MR (B)(6) LEFT A VOICE MAIL INDICATING THAT THIS WAS A "COURTESY CALL" TO ADVISE OF AN INCIDENT INVOLVING A PT WHO RECEIVED BURNS OF THE SECOND AND THIRD DEGREE DURING A PROCEDURE ON (B)(6) 2014. (B)(4) CONDUCTED A COMPLAINT INVESTIGATION, INCLUDING A FOLLOW UP CALL ON (B)(4) 2014 WITH (B)(6) THAT CONFIRMED THAT A LUMITEX LIGHTMAT UA2550 ANDA LUXTEC XENON MLX 300 LIGHT SOURCE WERE USED DURING THE REPORTED PROCEDURE. IT SHOULD BE NOTED THAT THE INDICATIONS FOR USE (IFU) LISTS RECOMMENDED LIGHT SOURCES, AND THE MLX300 LIGHT SOURCE IS NOT A RECOMMENDED SOURCE. FURTHER, THE IFU WARNS TO CLOSELY MONITOR CONNECTOR HEAT WHEN NOT USING A RECOMMENDED LIGHT SOURCE. DURING THE SURGICAL PROCEDURE, THE EXPOSED CONNECTOR MADE CONTACT WITH BARE SKIN CAUSING A 4 MM X 3 MM BURN. THE IFU SPECIFICALLY WARNS AGAINST PLACING THE CONNECTOR AGAINST PT SKIN TO PREVENT BURNS. THE INVESTIGATION WAS CLOSED ON 04/17/2014 WITH NO FURTHER ACTION AFTER MULTIPLE ATTEMPTS TO PROVIDE AN ON-SITE IN-SERVICE WERE REPEATEDLY REJECTED. THIS FORM FDA 3500A WAS GENERATED IN RESPONSE TO A MEDWATCH REPORT ENTERED INTO THE MEDWATCH SYSTEM IN MARCH OF THIS YEAR AND RECEIVED AT LUMITEX ON 03/10/2015 FOR THE (B)(6) 2014 INCIDENT.

    Description of Event or Problem · 1

    LUMITEX MD LIGHTMAX SURGICAL ILLUMINATOR, MODEL UA2550, WAS USED DURING THE BILATERAL MASTECTOMY PROCEDURE. THE ILLUMINATOR WAS CONNECTED TO A GYRUS ACMI C93 4 MM FIBER OPTIC LIGHT CABLE AND USED AN INTEGRA LUXTEC 300 MLX XENON LIGHT SOURCE. THE SURGEON PERFORMING THE PROCEDURE NOTED DURING THE FIRST PART OF THE PROCEDURE, THERE WAS A BURN OVER THE STERNUM AREA OF THE PT. IT WAS FURTHER NOTED (IN THE SUPPLIED FORM FDA 3500 REPORT) THAT THE METAL CONNECTION BETWEEN THE LIGHT CABLE AND THE ILLUMINATOR APPEARED TO HAVE COME IN CONTACT WITH THE SKIN IN THE AREA OF THE STERNUM. THE REPORT FURTHER STATED THE BURN COVERED AN ESTIMATED AREA OF 4 CM X 3 CM IN SIZE AND APPEARED TO BE MOSTLY SUPERFICIAL AND PARTIAL THICKNESS. IT WAS ALSO REPORTED THAT AN ESTIMATED 2 CM X 1 CM PORTION OF THE BURN INJURY APPEARED TO BE A FULL THICKNESS R=BURN AND THAT THERE WERE A COUPLE OF VERY SMALL PUNCTATE AREAS OF BURN ON THE LEFT UPPER CHEST WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228533 LIGHTMAT SURGICAL ILLUMINATOR LIGHTMAT ULTRA THIN HJN LUMITEX, INC. UA 2550 102659

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention