BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMITEX MD LIGHTMAT SURGICAL ILLUMINATOR

    MDR report key: 4616989 · Received March 16, 2015

    Report

    Report Number
    MW5041509
    Event Type
    Injury
    Date Received
    March 16, 2015
    Date of Event
    February 11, 2014
    Report Date
    March 5, 2015
    Manufacturer
    LUMITEX MD, INC
    Product Code
    HJM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A LIGHTMAT SURGICAL ILLUMINATOR BY LUMITEX MD (REF#UA2550, LOT 102659) WAS BEING USED DURING A BILATERAL MASTECTOMY PROCEDURE. THE ILLUMINATOR WAS CONNECTED TO A GYRUS ACMI G93 4 MM FIBER OPTIC LIGHT CABLE WHICH WAS CONNECTED TO AN INTEGRA LUXTEC 300 MLX XENON LIGHT SOURCE. THE SURGEON NOTED DURING THE FIRST PART OF THE PROCEDURE THAT THE ILLUMINATOR LIGHT WAS DIM. IT WAS THEN NOTED THAT THE SKIN OVER THE STERNUM HAD BEEN BURNED. 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 BURN COVERED AN ESTIMATED 4 X 3 CM AREA THAT APPEARED TO BE MOSTLY SUPERFICIAL AND PARTIAL THICKNESS. AN ESTIMATED 2 X 1 CM PORTIONS OF THE BURN INJURY APPEARED TO BE A FULL THICKNESS BURN. THERE WERE ALSO 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
    179256 LUMITEX MD LIGHTMAT SURGICAL ILLUMINATOR LIGHTMAT SURGICAL ILLUMINATOR HJM LUMITEX MD, INC 102659

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention