BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGADYNE

    MDR report key: 1728538 · Received June 16, 2010

    Report

    Report Number
    1728538
    Event Type
    Malfunction
    Date Received
    June 16, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 16, 2010
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE (1) CORONARY BYPASS X 3 (L) INTERNAL THORACIC ARTERY TO (L) ANTERIOR DESCENDING ARTERY, SAPHENOUS VEIN GRAFT TO OBTUSE MARGINAL BRANCH OF CIRCUMFLEX ARTERY, SAPHENOUS VEIN GRAFT TO SECOND DIAGONAL BRANCH OF THE (L) ANTERIOR DESCENDING (2)(L)LOWER EXTREMITY ENDOSCOPIC GREATER SAPHENOUS VEIN HARVEST THERE WAS NOTED TO BE A SMALL AIR LEAK FROM THE LUNG. DURING BOVIE USE, THERE WAS A QUICK FLASH OF FLAME WHICH LEFT A MILD BURN ON THE VISCERAL PLEURA. A SMALL HOLE LEAKING ANESTHETIC GAS WAS REPAIRED WITH CHROMIC STITCH, AND THE PT WAS GIVEN HEPARIN. THE PROCEDURE CONTINUED, WAS COMPLETED, CLOSED AND PT WAS TRANSFERED TO ICU IN CRITICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGADYNE CAUTERY WAND GEI MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE E-Z CLEAN *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR CARDIAC DRUGS