BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOVIE MEDICAL

    MDR report key: 1810616 · Received July 28, 2010

    Report

    Report Number
    3007593903-2010-00003
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 27, 2010
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K945764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND WE CANNOT DETERMINE A ROOT CAUSE FOR THE EVENT. THE USER FACILITY REPORTER INDICATES THAT THE DEVICE WAS PREPARED FOR DISPOSAL (CAUTERY TIP WAS CUT AND CAP REPLACED) IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THEY INDICATE THAT THE TIPS CONTACTED GAUZE WITHIN THE SHARPS CONTAINER AND IGNITED. WITH TIPS CUT, THE POWER CIRCUIT OF THE CAUTERY IS DISRUPTED AND THE TIP CANNOT HEAT UP.

    Description of Event or Problem · 1

    FLAMES AND SMOKE WERE NOTICED COMING OUT OF A WALL MOUNTED SHARPS CONTAINER. USER FACILITY SUBMITTED FDA MDR REPORT # (B)(4). USER STATED THAT CAUTERY TIPS WERE CUT PER IFU AND COVER CAP WAS REAPPLIED, BUT WAS NOT COMPLETELY "CLICKED" IN PLACE. PER FACILITY INCIDENT REPORT, 2 CAUTERIES CAME IN CONTACT WITH GAUZE IN THE SHARPS CONTAINER AND IGNITED. NO STAFF OR PATIENTS WERE INJURED AS A RESULT OF THIS INCIDENT. PRODUCT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOVIE MEDICAL CAUTERY DEVICE GEI BOVIE MEDICAL CORPORATION AA21 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK