BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXENON XI 300

    MDR report key: 3788106 · Received April 23, 2014

    Report

    Report Number
    3788106
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 23, 2014
    Manufacturer
    QED, INC
    Product Code
    EQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING MASTECTOMY, SURGEON USED LIGHTED RETRACTOR WITH STORZ LIGHT CORD THAT WAS ATTACHED TO LIGHT SOURCE. A FEW MINUTES LATER, BURNING SMELL CAME FROM LIGHT SOURCE AND LIGHT CORD. TIP OF LIGHT CORD WHERE IT WAS PLUGGED IN TO LIGHT SOURCE LOOKED BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247083 MAXENON XI 300 LIGHT, SURGICAL, FIBEROPTIC EQH QED, INC 3010 *
    247084 STORZ BFW ILLUMINATOR ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD HBI BAUSCH & LOMB, INC. BFW 3010 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR