BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN ELECTROSURGICAL GENERATOR

    MDR report key: 7767959 · Received August 9, 2018

    Report

    Report Number
    MW5078942
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    July 25, 2018
    Report Date
    July 30, 2018
    Manufacturer
    COVIDIEN / MEDTRONIC, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, SURGEON WAS USING A COVIDIEN FT10 ELECTROSURGICAL GENERATOR UNIT (ESU) SERIAL # (B)(4) AND A MEGADYNE BOVIE NEEDLE TIP - LOT #183471 AND ENCOUNTERED A SPARK AND A SMALL FLAME IN THE OPERATING ROOM. STAFF REMOVED THE TIP AND REPLACED IT WITH A REGULAR MEGADYNE BOVIE TIP - LOT #180191 AND AGAIN ENCOUNTERED SPARKS AND A SMALL FLAME. STAFF REMOVED THE ESU UNIT AND REPLACED IT WITH ANOTHER ESU - SERIAL # (B)(4). THEN, THEY PLACED THE SECOND MEGADYNE BOVIE TIP WITH LOT # 180191 ON THE NEW UNIT AND NO ADD'L SPARKS OF FLAME OCCURRED. THE INITIAL UNIT WAS SET AT 30 CUT AND 30 COAG WITH THE SPARK AND FLAME OCCURRED. THEN, THE UNIT WAS TURNED DOWN TO 20 CUT AND 20 COAG WITH THE SAME RESULT. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608810 COVIDIEN ELECTROSURGICAL GENERATOR ELECTROSURGICAL CUTTING AND COAGULATION GEI COVIDIEN / MEDTRONIC, INC. 183471
    608811 MEGADYNE BOVIE NEEDLE TIP ELECTROSURGICAL CUTTING AND COAGULATION GEI MEGADYNE / ETHICON ENDO-SURGERY INC. MEGADYNE BOVIE X2 180191

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR