BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHT SOURCE

    MDR report key: 2801514 · Received October 18, 2012

    Report

    Report Number
    1222895-2012-00033
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    FST
    PMA / PMN Number
    K081477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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

    THE CUSTOMER INITIALLY REPORTED THE AX-1370-BIF ULTRALITE PLUS MODULE HEADLIGHT SYSTEM, SERIAL NUMBER (B)(4) WAS BURNED THROUGH DURING A PROCEDURE. THE 00MLX LIGHT SOURCE, SERIAL NUMBER (B)(4) WAS USED DURING PROCEDURE WHEN MODULE MELTED/BURNED. THE AX-1370-BIF WAS PURCHASED IN 2003. BOTH THE LIGHT SOURCE AND HEADLIGHT SYSTEM ARE BEING RETURNED FOR INVESTIGATION. (B)(6) 2012 CUSTOMER REPORTS VIA PHONE THERE WERE NO PT OR PERSONNEL ISSUES. DOCTOR WAS PERFORMING ORAL SURGERY. THIS SAME HEADLIGHT WAS USED WITH A DIFFERENT 00MLX LIGHT SOURCE BY THIS SAME DOCTOR JUST PRIOR TO THE DOCTOR GOING TO HIS SECOND PROCEDURE. THERE WAS NO DAMAGE TO THE AX-1370-BIF HEADLIGHT DURING THE FIRST PROCEDURE. THE 00MLX REPORTED HERE WAS THE ONE USED FOR THE SECOND PROCEDURE WHEN THE AX-1370-BIF DAMAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MLX 300W XENON LIGHT SOURCE NA FST INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 AX-1370-BIF ULTRALITE PLUS MODULE HEADLIGHT SYSTEM| SERIAL NUMBER (B)(4)