BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXENON XI 300

    MDR report key: 4040147 · Received June 4, 2014

    Report

    Report Number
    1037039-2014-00001
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 23, 2014
    Manufacturer
    QED INC
    Product Code
    FST
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE #2. ILLUMINATOR, FIBER OPTIC, SURGICAL FIELD. BRAND NAME: STORZ BFW ILLUMINATOR, AGE OF DEVICE: DO NOT KNOW, SINGLE USE DEVICE: NO, SERIAL #(B)(4), MODEL#: BFW 3010, RETURNED TO MFR: NO, AVAILABLE FOR EVALUATION: YES, PROCODE: UNK. THE MAXENON XI 300, X/N (B)(4) WAS SOLD(B)(4) 20 07 TO BFW INC AN HAS NO HISTORY OF COMPLAINTS OR REPAIRS PERFORMED AT THE MANUFACTURER FACILITY. IT IS DESIGNED WITH AN INTENDED USE AS A FIBER OPTIC HEADLIGHT SYSTEM. THE DESCRIPTION OF THE EVENT/PROBLEM STATES THAT THE DEVICE WAS BEING USED IN A SURGICAL PROCEDURE WITH A LIGHTED RETRACTOR, WHICH IS NOT THE INTENDED USE OF THE DEVICE. THE REPORT STATES THAT THE DEVICE WAS SUBJECTED TO EVALUATION AND TESTING ON (B)(6) 2014. THE EVALUATION SAYS THE FIBER OPTIC CABLE USED IN THE PROCEDURE WAS FROM AN UNKNOWN MANUFACTURER. THE FINDINGS LISTED IN THE REPORT VERIFY THAT THERE WERE NO MALFUNCTIONS OF THE POWER SUPPLY OR INTERNAL WIRING. WHEN CONNECTED TO A BFW HEADLIGHT AND CABLE, IT RAN FOR THREE HOURS WITH NO PROBLEMS. THE MANUFACTURER AGREES WITH THE TEST LAB REGARDING POSSIBLE CONTRIBUTING FACTORS. THE MAXENON XI OPERATION MANUAL STATES THAT THE FIBER OPTIC CABLE MUST BE RINSED FREE OF SOAKING/DISINFECTANT SOLUTION AND DRIED BEFORE PLUGGING INTO A PORT. BFW INC RECOMMENDS FIBER OPTIC CABLES MADE BY THE ORIGINAL MANUFACTURER AS IDENTIFIED ON THE PORT TURRET. REFURBISHED CABLES MAY MALFUNCTION RESULTING IN DAMAGE TO THE LIGHT SOURCE AND/OR CABLE. IF USING THE LIGHT SOURCE WITH A NON-BFW PRODUCT, IT IS THE USER'S RESPONSIBILITY TO ASSURE THE COMPATIBILITY. THE MEDWATCH REPORT LEADS THE MANUFACTURER TO CONCLUDE THAT THE DEVICE WASN'T USED AS INTENDED BY THE DEVICE DESIGN. A FIBER OPTIC CABLE FAILURE CAUSED THE PROBLEM. THE USE FACILITY FAILED TO ADHERE TO WARNINGS AND RECOMMENDATIONS IN THE OPERATION MANUAL.

    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 INTO LIGHT SOURCE LOOKED BURNED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: BILATERAL MASTECTOMY AND RECONSTRUCTION WITH BREAST EXPANDER. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION-THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327045 MAXENON XI 300 LIGHT, SURGICAL, FIBER OPTIC FST QED INC 3010 30-

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other