BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGADYNE

    MDR report key: 6209084 · Received December 26, 2016

    Report

    Report Number
    MW5066926
    Event Type
    Injury
    Date Received
    December 26, 2016
    Date of Event
    December 23, 2016
    Report Date
    December 26, 2016
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON USED THE MEGADYNE BOVIE TIP TO #160595) AT CUT AND COAG SETTING 35. THE SURGEON HAD REQUESTED TO INCREASE THE CUT SETTING TO 45. AFTER USING THE BOVIE IN THIS SETTING FOR APPROX 15 MINUTES, THE SURGEON ALERTED THE TEAM THAT IT ARCHED FROM THE SIDE OF THE BOVIE TIP TO THE PT'S SKIN NEAR THE SURGICAL SITE AT THE RIGHT AREOLA. THE BURN SITE WAS SMALL AND IRREGULAR SHAPED. THE PROCEDURE WAS PAUSED AND A BOVIE TIP WITH A DIFFERENT LOT NUMBER WAS RETRIEVED AND REPLACED BY THE SURGICAL TECH. THE SURGEON AND TECH DID NOT SUFFER ANY INJURIES. NEW BOVIE TIP WAS TESTED AND NO APPARENT ISSUES WERE FOUND. NO EQUIPMENT MALFUNCTION WAS FOUND WITH THE BOVIE MACHINE AND GROUNDING PAD. THE SURGEON EXCISED AFFECTED AREA AND PROCEEDED WITH SURGERY. NO FURTHER ISSUES. EVENTS LEADING UP TO THE INCIDENT. PRIOR TO THE CASE, THE SURGICAL TECH OPENED THE BOVIE TIP ONTO THE STERILE FIELD AND INSPECTED IT FOR DEFECTS, NONE WERE FOUND. THE TIP WAS SECURED ON THE HAND PIECE BEFORE USAGE. THE RN CONFIRMED THAT THE PT HAD NO METAL/IMPLANTED DEVICES. THE RN ALSO ENSURED THAT THERE WERE NO WET SURFACE ON THE PT. AREA DRIED AFTER PREP WAS APPLIED. IN ADDITION, THE RN SECURED THE GROUNDING PAD TO THE RIGHT ANTERIOR LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853980 MEGADYNE BOVIE TIP GEI MEGADYNE MEDICAL PRODUCTS 160595

    Patients

    Seq Age Sex Outcome Treatment
    1 Other