BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 4440350 · Received January 20, 2015

    Report

    Report Number
    1222895-2015-00003
    Event Type
    Injury
    Date Received
    January 20, 2015
    Date of Event
    February 11, 2014
    Report Date
    December 8, 2014
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    FCW
    PMA / PMN Number
    K081477
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 06/22/2015 CUSTOMER MEDWATCH (IDENTIFICATION NUMBER) REPORTS ADDITIONAL INFORMATION. THE REPORTED DEVICE IS NOT AN INTEGRA DEVICE. "A LIGHTMAT SURGICAL ILLUMINATOR BY LUMITEX MD ( REF# UA2550 LOT# 1026591) WAS BEING USED DURING A BILATERAL MASTECTOMY PROCEDURE. THE ILLUMINATOR WAS CONNECTED TO A GYRUS ACMI C93 4MM 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 HAS 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 X3 CM AREA THAT APPEARED TO BE MOSTLY SUPERFICIAL AND PARTIAL THICKNESS AN ESTIMATED 2X1 CM PORTION OF THE BURN INJURY APPEARED TO BE A FULL THICKNESS BURN. THERE WERE ALSO A COUPLE OF VERY SMALL BURNS ON THE LEFT UPPER CHEST WALL.

    Additional Manufacturer Narrative · 1

    METHOD: FAILURE ANALYSIS, DEVICE EVALUATION HISTORY. RESULTS, FAILURE ANALYSIS - UNABLE TO COMPLETE FAILURE ANALYSIS AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION. DEVICE EVAL HISTORY: NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY. THERE IS NO APPLICABLE NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL. REPORT HISTORY: VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE - ACTION HISTORY: THERE IS NO APPLICABLE CORRECTIVE ACTION PREVENTIVE ACTION HISTORY. HEALTH HAZARD EVALUATION HISTORY: THERE IS NO APPLICABLE HEALTH HAZARD EVALUATION HISTORY. REPAIR HISTORY: NA. CONCLUSION: UNABLE TO COMPLETE ROOT CAUSE ANALYSIS AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    PT RECEIVED BURNS DURING A BILATERAL PROPHYLACTIC AREOLA SPARING MASTECTOMY AND PLACEMENT TISSUE EXPANDER SURGERY. AS A RESULT OF THESE BURNS, PT HAS UNDERGONE SKIN GRAFTS AND OTHER MEDICAL CARE AND TREATMENT. THE BURNS HAVE RESULTED IN SIGNIFICANT SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47649 MLX 300W XENON LIGHTSOURCE NA FCW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other GYRUS ((B)(4) 4-MM FIBRE OPTIC LIGHT CABLE)