One of Johnson & Johnson’s medical device subsidiaries is pulling one of its pediatric electrosurgery devices from the market after it and similar models were subject to a series of recalls over the past several months following reports of patient burns.
Ethicon’s Megadyne division previously recalled its Mega Soft and Mega 2000 return electrodes in June 2023. The flat, reusable pads are placed separately on the skin of the patient to help complete the circuit and return the electricity employed by a powered cutting instrument during a procedure.
Previously labeled a Class I recall by the FDA, the agency’s most serious category, the company’s effort spanned 21,100 devices distributed to hospitals and surgery centers over a two-year period. The FDA has said it collected reports of at least 99 injuries, including some as severe as third-degree burns, and zero patient deaths.
That recall was expanded upon in December 2023, to update certain devices’ product labeling and restrict their use to patients 12 years of age and older, covering some 9,500 units.
The Mega Soft pediatric patient electrode, model # 0840 (Megadyne)
Now, because one particular model had been designed specifically for patients weighing between 0.8 and 50 pounds, the company has elected to discontinue that electrode return pad and remove it from the global market.
“A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential for thermal injuries,” J&J’s Megadyne said in its announcement. “The combination of these conditions may be more likely when the pad is used with infants and small children … Between 2018 and today, there have been 4 reported injuries and no reports of death associated with this product.”
The company added that healthcare providers should closely follow all proper cleaning, placement and setup steps for the Mega Soft pads.
Three other pad models, indicated for patients 25 lbs and over, have not seen changes to their instructions for use.
Ethicon acquired devicemaker Megadyne in January 2017 for an undisclosed amount, while estimating that electrosurgical devices are used in nearly 80% of all procedures.