BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA 300 XENON

    MDR report key: 2994044 · Received March 1, 2013

    Report

    Report Number
    2994044
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    November 2, 2012
    Report Date
    March 1, 2013
    Manufacturer
    QED MEDICAL, INC
    Product Code
    FST
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEAR THE END OF AN INCISIONAL HERNIA REPAIR ON A PATIENT, THE SURGEON NOTICED SLOUGHING OF THE SKIN AND INDURATION IN THE PERIUMBILICAL REGION. THIS INDURATION RESEMBLED A LOCALIZED 2ND DEGREE BURN. PER STAFF, THE SURGICAL HEADLAMP AND OVERHEAD LIGHT DID NOT SEEM EXCESSIVE AND OTHER SKIN AREAS EXPOSED TO SKIN PREP WERE UNAFFECTED. THIS BURN IS NOT RELATED TO USE OF AN ELECTROSURGICAL CUTTING/COAGULATION DEVICE. A WEEK LATER ANOTHER CHILD WAS UNDERGOING A SIMILAR PROCEDURE IN THE SAME ROOM AND ALSO SUSTAINED AN IDENTICAL INJURY. WE HAD OUR BIO MEDICAL DEPARTMENT INVESTIGATE A POSSIBLE CAUSE OF THE BURNS. BIO MED FOUND NOTHING WRONG WITH THE LIGHT SOURCE. THE LIGHT SOURCE WAS THEN SENT BACK TO THE MANUFACTURER AND THE MANUFACTURER RETURNED THE EQUIPMENT STATING THAT THE INCORRECT BULB HAD BEEN USED. BIO MED DID FURTHER TESTING AND WAS UNABLE TO SAY WITH CERTAINTY THAT THE INCORRECT LAMP COULD HAVE CAUSED THE BURN. HOWEVER, THE CORRECT LAMP WOULD HAVE HAD A FILTER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PATIENT WAS UNGOING A SURGICAL PROCEDURE AND THE LIGHT SOURCE WAS BEING USED TO VISUALIZE THE SURGICAL FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88897 NOVA 300 XENON LIGHT SOURCE, FIBEROPTIC FST QED MEDICAL, INC * *
    88898 SOLARMAXX LIGHT SOURCE, FIBEROPTIC, ROUTINE FCW SUNOPTIC TECHNOLOGIES, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO