BEUDAMED
    FDA Adverse Event Summary report: N

    LUXTEC

    MDR report key: 2963436 · Received February 10, 2013

    Report

    Report Number
    2963436
    Date Received
    February 10, 2013
    Date of Event
    December 28, 2012
    Report Date
    February 8, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    FCW
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT'S LEFT ANTERIOR NECK WAS BURNED WITH MEDIASTINAL SCOPE LIGHT SOURCE. THIS WAS NOTICED BY HO AT END OF CASE. THIS WAS BROUGHT TO THE ATTENTION OF MD WHO SUGGESTED APPLYING BACITRACIN OINTMENT TO THE SITE. BURN WAS APPROXIMATELY A DIME SIZED WHITE AREA.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?FLEXIBLE BRONCHOSCOPY, MEDIASTINOSCOPY, LEFT UPPER LOBECTOMY, AND MEDIASTINAL LYMPH NODE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58000 LUXTEC LIGHT SOURCE, ENDOSCOPE, XENON ARC FCW INTEGRA LIFESCIENCES CORPORATION 9300XSP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR