MEGA Reusable Patient Return Electrodes Recall

WHAT IS A REUSABLE PATIENT RETURN ELECTRODES AND HOW IS IT USED?

MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes are soft pads used during electrosurgery, where an electric current is used to heat or cut tissue or to stop bleeding.

Specifically, 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.

WHAT GUIDELINES HAVE BEEN GIVEN?

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.

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.