BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGADYNE ELECTROSURGICAL PENCIL

    MDR report key: 4195833 · Received October 21, 2014

    Report

    Report Number
    1721194-2014-00003
    Event Type
    Injury
    Date Received
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    PMA / PMN Number
    K965054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT LOT NUMBER INFO WE ARE UNABLE TO IDENTIFY THE MFR DATE. WITHOUT LOT NUMBER INFO WE ARE UNABLE TO PERFORM A REVIEW OF THE LOT HISTORY RECORD. A REVIEW OF THE PRODUCT HISTORY REVEALS THIS DEVICE TO BE A RELIABLE COMPONENT OF ELECTROSURGERY AND THERE IS NO EVIDENCE TO SUGGEST A DEVICE DEFECT OR MALFUNCTION. AS REPORTED BY THE USER, INGRESS OF FLUIDS FROM EXPOSURE TO THE MISTA BLOWER IS THE MOST LIKELY CAUSE. DEVICE MEETS THE REQUIREMENTS OF (B)(4) 3RD EDITION FOR FLUID INGRESS. MEGADYNE DETERMINED THIS EVENT IS RELATED TO USE BEYOND THE SCOPE OF THE DESIGN AND THE INTENDED USE OF THE DEVICE. USER FACILITY DETERMINED EVENT IS NOT REPORTABLE. MEGADYNE IS REPORTING BECAUSE REPORT INDICATED INTERVENTION WAS REQUIRED. MEGADYNE CAUTIONED THE USER AGAINST USE OF THE HANDPIECE IN THIS APPLICATION.

    Description of Event or Problem · 1

    INADVERTENT ACTIVATION DURING CARDIAC PROCEDURE. ON (B)(6) 2014 ADDITIONAL INFO RECEIVED, DR WAS PERFORMING A BYPASS SURGERY USING MEGADYNE PENCIL AND MEGA SOFT PAD WITH A VALLEY LAB GENERATOR. A MISTA BLOWER WAS USED WHICH SPRAYS WATER ON THE HEART DURING PROCEDURE. THEY NOTICED FLUID WAS GETTING INTO PENCIL BUT DID NOT CHANGE OUT PENCIL. DR STATED HE DID NOT PRESS ANY BUTTONS NOR WERE FOOT SWITCHES USED AND THE PENCIL ACTIVATED ON ITS OWN. NURSE AND ASSISTANT WERE WITNESSED TO THIS. WHEN PENCIL ACTIVATED THE PENCIL CUT THE MEMORY ARTERY THAT WAS BYPASSED AND DR HAD TO RE-HEPARINIZE PT AND REPAIR ANASTOMOSIS (RE-DO BYPASS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670071 MEGADYNE ELECTROSURGICAL PENCIL ELECTROSURGICAL PENCIL GEI MEGADYNE MEDICAL PRODUCTS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R