Megadyne Recalls MEGA 2000 And MEGA Soft Reusable Patient Return Electrodes: MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes are soft pads used during electrosurgery.  In electrosurgery, an electric current is used to heat or cut tissue or to stop bleeding.  The electric current is generated by an electrosurgical generator and delivered to the tissue with a small pen-like attachment.  A return electrode pad contacts the skin of the laying patient during use and conducts the electric current from the patient’s tissue back to the electrosurgical unit, or generator, to reduce the risk of excessive heating. 

Megadyne is recalling MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes after receiving reports of patients receiving burn injuries from use in both pediatric and adult patients. These burns may be as serious as third-degree burns requiring medical intervention and may lead to a longer hospital stay, scarring, and potentially more surgeries for pediatric and adult patients. Megadyne is continuing to evaluate the root cause for patient burns. 

Use of affected products may cause serious injury or death. Megadyne reports 63 injuries and no deaths related to this issue. 

On June 1, 2023, Megadyne sent an Urgent Medical Device Correction letter to customers that included the following recommended actions:

  • Share the notification with all users involved in MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes cleaning, operating room and patient setup, and device operation during procedures.
  • Confirm that personnel using the MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes are following the instructions for use as shown in the letter and available at: https://www.eifu.com.
  • Post the “Cleaning and Care Visual Aid and Placement and Setup Visual Aid,” both included as attachments to the letter, near the operating room to remind staff about instructions for cleaning and setup.
  • Contact any facilities where products may have been shared. 
  • Complete the Business Reply Form attached to the letter.
  • Fax the form to 888-214-7430 or email it to Sedgwick at [email protected] within three (3) business days.
  • For additional copies of this communication or questions about returning affected products contact Sedgwick at 888-843-0254 and reference Event # 5627.
  • If medical engagement with manufacturer is requested, health care providers should submit the request using the Medical Information Request website: https://www.jnjmedtech.com/mir.

The letter also noted that health care providers who have used MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes during patient procedures should follow patients post-operatively in the same way with no additional action required related to the correction.

Source

We have received inquiries from surgical patients who experienced serious unexplained burns during surgery and we are investigating such claims.

If you or a loved one may have suffered a serious burn during surgery, you should promptly find a medical malpractice lawyer in your state who may investigate your surgical burn malpractice claim for you and represent you or your loved one in a surgery burn medical malpractice case, if appropriate.

Click here to visit our website or call us toll-free in the United States at 800-295-3959 to find medical malpractice attorneys in your U.S. state who may assist you.

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