BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXENON XI 300-WATT XENON LIGHT SOURCE

    MDR report key: 3370099 · Received September 16, 2013

    Report

    Report Number
    3005775121-2013-00001
    Event Type
    Injury
    Date Received
    September 16, 2013
    Date of Event
    June 13, 2013
    Report Date
    September 10, 2013
    Manufacturer
    QED, INC
    Product Code
    FST
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BFW, INC (RELABELER OF THIS DEVICE) RECEIVED A CALL FROM THE FACILITY ON (B)(4) 2013 REPORTING THAT DURING A SURGICAL PROCEDURE USING THE MAXENON XI 300-WATT XENON LIGHT SOURCE AND HIGH BEAM FIBER OPTIC HEADLIGHT, A PT WAS BURNED. ACCORDING TO THE FACILITY, THE EVENT OCCURRED (B)(6) 2013. THE FACILITY INFORMED BFW THAT THE MAXENON XI HAD BEEN SENT TO A NON-BFW REPAIR FACILITY ON 06/11/2013, PHYSICIANS BIOMED, TO HAVE THE 300-WATT XENON LAMP REPLACED. THE XENON LAMP FOR THE MAXENON XI REQUIRES A COOLING RING/HEAT SHIELD COMPONENT BE REMOVED FROM THE OLD LAMP AND INSTALLED ON THE NEW LAMP PRIOR TO INSERTING THE LAMP INTO THE HOUSING AND BACK INTO THE LIGHT SOURCE OR EXCESSIVE TEMPERATURES WILL OCCUR. THIS IS NOTED SEVERAL TIMES IN THE OPERATION MANUAL. IT IS ALSO STATED IN THE MANUAL THAT LAMPS NOT PURCHASED AND INSTALLED BY BFW WILL NOT BE WARRANTED. UPON RECEIPT OF THE MAXENON XI LIGHT SOURCE FROM THE FACILITY IT WAS FOUND THAT THE LAMP WAS PLACED INTO THE LIGHT SOURCE WITHOUT THE COOLING RING/HEAT SHIELD. THE HIGH BEAM HEADLIGHTS AND FIBER OPTIC CABLES RECEIVED AT BFW FROM THE FACILITY WERE IMPACTED BY THE EXCESSIVE HEAT AS WELL. THE MAXENON XI WAS SOLD TO THE FACILITY IN MARCH OF 2006. THIS FACILITY HAS NOT PURCHASED XENON LAMPS FROM BFW. THE FACILITY SENT IN MAXENON XI LIGHT SOURCE, TWO HIGH BEAM HEADLIGHTS WITH FIBER OPTIC CABLES. UPON RECEIPT, THE LAMP WAS CHECKED AND FOUND TO BE INSTALLED WITHOUT THE COOLING RING/HEAT SHIELD. EQUIPMENT WAS SENT TO THE ORIGINAL MFR (QED, INC) WHO CONFIRMED THE SAME. WITH A REPLACEMENT LAMP THAT INCLUDES THE COOLING RING/HEAT SHIELD THE UNIT WILL OPERATE SAFELY WAS DESIGNED.

    Description of Event or Problem · 1

    ON (B)(4) 2013, BFW RECEIVED A CALL FROM (B)(6) REGARDING A PROCEDURE INVOLVING THE MAXENON XI-300WATT XENON LIGHT SOURCE AND HIGH BEAM FIBER OPTIC HEADLIGHT THAT RESULTED IN A BURN TO A PT. THE EVENT OCCURRED (B)(6) 2013, HOWEVER, BFW ONLY BECAME AWARE OF THE EVENT (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464364 MAXENON XI 300-WATT XENON LIGHT SOURCE MAXENON XI FST QED, INC MID 3010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA