BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXENON XI 300

    MDR report key: 4072749 · Received September 5, 2014

    Report

    Report Number
    3005775121-2014-00002
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 14, 2014
    Manufacturer
    QED, INC.
    Product Code
    FST
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BFW, INC. WAS THE DISTRIBUTOR OF THIS PRODUCT BUT NO LONGER REPRESENTS OR SELLS THIS PRODUCT. THE MFR IS QED, INC. CUSTOMER USED LIGHT SOURCE OFF-LABEL WITH RETRACTOR AND FIBER OPTIC CABLE. CABLE MAY HAVE OVERHEATED WHEN UNIT WAS TURNED ON. NO HARM TO PT OR STAFF. UPON RECEIPT AT REPAIR FACILITY, UNIT WAS FOUND TO HAVE BEEN PHYSICALLY DAMAGED WITH BENT FRAME. LAMP TIMER IS EXPIRED AND LAMP IS NOT THE ORIGINAL LAMP NOR WAS IT PURCHASED FROM BFW. LIGHT OUTPUT WAS MEASURED AT 7,515 FOOT CANDLES. CABLE AND RETRACTOR WERE INCLUDED, NO BRANDING FOUND. WITH NO INFO KNOWN ABOUT THE CABLE AND RETRACTOR, IT IS NOT POSSIBLE TO DETERMINE WHAT MIGHT HAVE HAPPENED TO THE FIBER OPTIC CABLE TO BLACKEN THE END. DEVICE DID NOT MALFUNCTION. DEVICE IS FOR USE WITH FIBER OPTIC HEADLIGHTS ONLY. DEVICE: FIBER OPTIC LIGHT CORD (S/N (B)(4)) IS NOT A BFW NOR QED PRODUCT.

    Description of Event or Problem · 1

    EVENT DESC: NURSE PASSED BEHIND THE BFW LIGHTBOX, SMELLED SMOKE, AND TURNED OFF THE LIGHTBOX; REMOVED THE LIGHT CORD USED FOR LIGHTED RETRACTOR 1.4 X 3.25 AND NOTICED BURNT (BLACK) MATERIAL AT THE TIP WHERE IT IS CONNECTED TO THE LIGHTBOX. ALSO NOTICED MIDDLE CORE IS BURNT. NO HARM TO PT OR STAFF. THE MAXENON XI 300 IS FOR USE WITH FIBER OPTIC HEADLIGHTS ONLY. ANY USE OF THE PRODUCT WITH OTHER EQUIPMENTS ONLY. ANY USE OF THE PRODUCT WITH OTHER EQUIPMENT IS CONSIDERED 'OFF-LABEL' AND AT THE USER'S DISCRETION. IT IS THE USER'S RESPONSIBILITY TO DETERMINE THE COMPATIBILITY OF OFF-LABEL PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544359 MAXENON XI 300 LIGHT, SURGICAL FST QED, INC. 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other