BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM SURGICAL FIBER OPTIC RETRACTOR

    MDR report key: 5684654 · Received May 27, 2016

    Report

    Report Number
    5684654
    Event Type
    Malfunction
    Date Received
    May 27, 2016
    Date of Event
    March 29, 2016
    Report Date
    May 13, 2016
    Manufacturer
    ELMED INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE THE LIGHTED BREAST RETRACTOR (#72-9851F, E0316) CONNECTED TO LIGHT BOX #137287 VIA LIGHT CORD #233-050-064 HEATED AT THE TIP OF THE RETRACTOR AND THE SURGICAL TOWEL ON THE MAYO STAND TO THE POINT OF VISIBLE SMOKE. THE RETRACTOR HAD BEEN ON THE MAYO STAND FOR "2 TO 3 MINUTES" PER THE STAFF. THE STAFF ALSO NOTED THE CONNECTION BETWEEN THE LIGHT CORD AND THE RETRACTOR WAS HOT TO THE TOUCH EVEN THROUGH THE SURGICAL GLOVES. THERE WAS NO PATIENT INJURY. EVALUATION BY CLINICAL ENGINEERING DID NOT FIND ANY DEFECTS OR PROBLEMS WITH THE EQUIPMENT. THE IFU FOR THE EQUIPMENT STATES "FIRE HAZARD. NEVER DRAPE OR COVER THE END OF ANY FIBER-OPTIC CABLE WITH ANYTHING FLAMMABLE." MANUFACTURER RESPONSE FOR FIBER OPTIC RETRACTOR, MILLENNIUM SURGICAL (PER SITE REPORTER): MANUFACTURER PROVIDED INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340355 MILLENNIUM SURGICAL FIBER OPTIC RETRACTOR RETRACTOR GAD ELMED INC. E0316

    Patients

    Seq Age Sex Outcome Treatment
    1 FIBER OPTIC LIGHT SOURCEFIBER OPTIC LIGHT CABLE