J&J’s Ethicon Recalls Megadyne Electrodes Over Burn Risk to Patients

The U.S. Food and Drug Administration (FDA) has identified Megadyne’s (a J&J Ethicon brand) June 1 recall of MEGA 2000 and MEGA soft reusable patient return electrodes as Class I.
 
In the U.S., 21,200 devices were recalled, which were distributed between March 11, 2021 and May 9, 2023.
 
The electrodes are soft pads used during electrosurgery. In electrosurgery, an electric current heats or cuts tissue or to stop bleeding. The 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 during use and conducts the current from the tissue back to the electrosurgical unit (or generator) to reduce risk of excessive heating.
 
Megadyne recalled the MEGA 2000 and MEGA SOFT electrodes after reports surfaced of both pediatric and adult patients sustaining burn injuries. The burns may be as serious as third-degree burns needing medical intervention, and might result in a longer hospital stay, scarring, and possibly more surgeries for both pediatric and adult patients.
 
Megadyne is continuing to assess the root cause for patient burns. The company reported 63 injuries and no deaths as of yet. In the Urgent Medical Device Correction letter to customers sent June 1, Megadyne recommended the notification be shared with all users involved in cleaning, operating room and patient setup, and device operation during procedures.

UPDATE 7/13/2023:
A spokesperson from J&J MedTech reached out to MPO to provide updates on the recall:

“At MEGADYNE, our first priority is to our customers and their patients, and that includes the safe and effective use of our products,” the spokesperson said. “During an investigation into reports of patient burns identified after surgical procedures in which Mega Soft pads were one of the devices used, it was determined that in some instances the Mega Soft pad Instructions for Use were not being properly followed. In collaboration with the U.S. Food and Drug Administration, we issued a notification to healthcare professionals who have purchased Mega Soft pads. The notification emphasized the importance of following the Instructions for Use, including proper cleaning and setup to help reduce the potential for a burn.”
 
“It is important to note that this notification was not a product removal and Mega Soft pads may continue to be used. Mega Soft pads remain available and, when used in accordance with the products’ labeling, are a safe alternative to disposable return electrodes.”
 
“A thorough investigation was conducted, and no design or manufacturing defects have been identified to date.”