BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE MAXCESS LIGHT GUIDE

    MDR report key: 1162272 · Received September 5, 2008

    Report

    Report Number
    2031966-2008-00005
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    July 25, 2008
    Report Date
    September 5, 2008
    Manufacturer
    NUVASIVE, INC.
    Product Code
    FST
    PMA / PMN Number
    K042034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED EVENT WAS NOT RETURNED TO NUVASIVE AND THE REPORTED MALFUNCTION COULD NOT BE VERIFIED. NUVASIVE IS SCHEDULING A VISIT TO THE HOSPITAL IN AN EFFORT TO PERFORM FIELD TESTING OF THE DEVICE AND THE HOSPITAL'S LIGHT SOURCE. A REVIEW OF THE DEVICE LABELING INDICATES THAT "LIGHT SOURCES USE HIGH INTENSIVE LAMPS, WHICH PRODUCE HEAT AS ELL AS BRILLIANT LIGHT. THE HIGH BRIGHTNESS PRODUCED BY THE LIGHT SOURCE AND THE LIGHT OUTPUT OF THE LIGHT GUIDE CABLE CAN CAUSE SERIOUS BURNS." THE ROOT CAUSE OF THE EVENT IS NOT KNOW AT THIS TIME, BUT THE INVESTIGATION IS STILL ONGOING. IN THE EVENT THAT NEW INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AT THE CONCLUSION OF A SURGICAL PROCEDURE USING AN ANGLED TIP LIGHT GUIDE, THE DEVICE WAS REMOVED FROM THE INSTRUMENT AND LIGHT SOURCE AND PLACED ON THE SIDE OF THE PATIENT. WHEN THE DRAPES WERE REMOVED, IT WAS NOTED THAT THERE WERE BURNS THROUGH THE DRAPES AND TOWEL, AND A SMALL BURN, APPROX. 4MM ON THE PATIENT WHERE THE TIP OF THE LIGHT GUIDE HAD RESTED. THE BURN WAS NOT SERIOUS AND NO ADDITIONAL TREATMENT OR INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUVASIVE MAXCESS LIGHT GUIDE SURGICAL LAMP FST NUVASIVE, INC. 3200060 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1