BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAUTERY TIP

    MDR report key: 3070659 · Received April 13, 2013

    Report

    Report Number
    1423395-2013-00006
    Event Type
    Injury
    Date Received
    April 13, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOVIE MEDICAL
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF A SURGICAL PROCEDURE, A 1/2 CM REDDENED AREA WAS IDENTIFIED THREE INCHES DISTAL TO THE MEDIAL INCISION LINE. IT WAS DETERMINED TO BE A MINOR BURN. IT IS NOT KNOWN WHEN THE BURN OCCURRED AND WAS THOUGHT TO HAVE ORIGINATED FROM THE CAUTERY TIP. THE TIP WAS NOT PRE-ATTACHED TO THE CAUTERY DEVICE AND HAD BEEN INSERTED INTO THE PENCIL BY THE CLINICIAN DURING THE PROCEDURE. IT IS NOT KNOWN OF THE CAUTERY TIP WAS ADEQUATELY SEATED ON THE PENCIL PRIOR TO USE. THE SURGICAL TECH REPORTED THAT THE BURN MAY HAVE OCCURRED WHEN SHE WAS HOLDING A HEMOSTAT AND THAT IT WAS POSSIBLE THAT IT ARCHED OFF THE CAUTERY TIP. BACITRACIN WAS APPLIED AND NO FURTHER INTERVENTION WAS INDICATED. THE CAUTERY PENCIL WAS RETURNED TO US BUT NOT THE TIP. THE PENCIL WAS TESTED AT MULTIPLE GENERATOR SETTINGS IN BOTH COAG AND CUT MODES, USING MULTIPLE CAUTERY TIPS AND PERFORMED AS INTENDED. FROM THE INFO WE HAVE GATHERED, USER ERROR MAY HAVE CAUSED THE BURN.

    Description of Event or Problem · 1

    UPON COMPLETION OF A SURGICAL PROCEDURE, A SMALL BURN WAS FOUND THREE INCHES DISTAL TO THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159884 CAUTERY TIP GEI BOVIE MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other