BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 12590631 · Received October 7, 2021

    Report

    Report Number
    2523190-2021-00206
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    September 15, 2021
    Report Date
    December 23, 2021
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    FCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MLX 300W XENON LIGHTSOURCE (00MLX) WAS RETURNED TO THE SERVICE AND REPAIR DEPOT FOR REPAIR ESTIMATE: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WERE OBSERVED. FAILURE ANALYSIS: THE DEPOT TECHNICIAN ASSESSMENT FOUND THAT THE FAULT WAS CONFIRMED. THE UNIT WAS NOT TURNING ON; THE LAMP WAS FAULTY. THE UNIT WAS EXTREMELY DUSTY. IT IS RECOMMENDED TO REPLACE THE PARTS AS PER ESTIMATE TO MEET MANUFACTURER'S SPECIFICATION. ROOT CAUSE ANALYSIS: THE RETURNED XENON LIGHTSOURCE WAS RECEIVED IN USED CONDITION WITH EXCESSIVE DUST INSIDE THE UNIT. DUST WOULD LEAD TO OVERHEATING AND POWER FAILURE. THE REPORTED COMPLAINT WAS CONFIRMED. NO FURTHER INVESTIGATION IS REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE XENON LIGHTSOURCE (00MLX) WAS NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED BECAUSE THE DESCRIBED FAILURE IS BEING ADDRESSED BY A QUALITY PLAN FOR ISSUES RELATING TO POWER SUPPLY FAILURE OF THE LAMP MODULE. AS AN INTERIM SOLUTION, INTEGRA CAN REPLACE COMPONENTS OF THE MLX LIGHTING UNITS TO RESTORE FUNCTIONALITY SHOULD CUSTOMER LATER RETURN THE DEVICE. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THERE WAS A FAULT CODE (ERR 22 111817) THAT APPEARED AFTER TURNING ON THE XENON LIGHTSOURCE (00MLX). AUDIBLE AND VISIBLE SPARKS CAN BE SEEN WHERE THE LIGHT IS SUPPOSED TO COME THROUGH. THERE IS AN ERROR CODE ON THE PANEL AND THE IMAGE ON THE PANEL SCREEN IS SOMETIMES CUT OFF ON THE RIGHT HALF. IN ADDITION, THE LIGHT IS ABLE TO EMIT AFTER ABOUT FIVE (5) MINUTES OF TURN ON TIME. THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY IN SURGERY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487983 MLX 300W XENON LIGHTSOURCE N/A FCW INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown