BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAUTERY DEVICE DEVICE WITHIN SURGICAL PACK

    MDR report key: 2803299 · Received October 12, 2012

    Report

    Report Number
    1417592-2012-00087
    Event Type
    Other
    Date Received
    October 12, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 5, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A BREAST PROCEDURE, THE SURGEON REACHED ACROSS THE ARM OF THE SURGICAL TECH TO PLACE THE CAUTERY DEVICE DOWN AFTER IT WAS USED. THE HOT TIP CAUSED A BURN IN THE SURGICAL GOWN AND THE TECH SUFFERED A SMALL BURN TO THE ARM. FIRST AID WAS PROVIDED TO THE TECH, BUT NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE CAUTERY DEVICE WAS RETURNED AND EVALUATED. IT WAS TESTED AND COMPARED TO A SIMILAR DEVICE FROM ANOTHER MFR. AFTER ACTIVATING THE PENCILS CONTINUOUSLY AT 40 WATTS CUT FOR 30-40 SECONDS, THE TIPS FOR BOTH DEVICES BURNED THROUGH SECONDS, BOTH TIPS COOLED ENOUGH TO TOUCH. NO MALFUNCTION WAS IDENTIFIED AND BOTH DEVICES PERFORMED AS INTENDED. THE INFO GATHERED DURING THE INVESTIGATION SUGGESTS THAT USER ERROR CAUSED THE INCIDENT AND THE SUBSEQUENT BURN.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE TECH REC'D A MINOR BURN WHEN HIS ARM TOUCHED THE TIP OF THE CAUTERY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAUTERY DEVICE DEVICE WITHIN SURGICAL PACK LRO MEDLINE INDUSTRIES, INC. 12GB1817/P1216005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other