FDA issues Class I recall for J&J unit’s electrosurgery pads
by
John R. Fischer, Senior Reporter | July 14, 2023
MEGA SOFT Reusable Patient Return Electrodes (Photo courtesy of Ethicon)
In what the FDA has classified as a “most serious” Class I recall, Megadyne, a unit of Johnson & Johnson MedTech subsidiary Ethicon Endo-Surgery, has issued a medical device correction letter to providers about improper use of its Mega soft reusable electrosurgery pads following reports of patient burns.
Acquired in 2017 by Ethicon Endo-Surgery, Megadyne designed the tools to conduct an electric current during surgery to heat or cut tissue and stop bleeding during procedures, selling them under the brand names, MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes.
In June, providers issued 63 reports of adults and pediatric patients being burned when the pads were applied during surgery, with some experiencing third-degree burns that required “medical intervention,” as well as a “longer hospital stay, scarring, and potentially more surgeries,” according to the FDA’s recall notice. No deaths were reported.
The recall affects 21,200 devices distributed between March 2021 and May 2023, but none have been removed and are still available, as Megadyne did not find any design or manufacturing defects. Instead, it found that in some cases, providers were using the devices incorrectly.
“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,” said Megadyne in a statement.
It says that improper use risks harm and, in some cases, death to patients, but that when used in accordance with their labeling, are safe alternatives to disposable return electrodes. It recommends that users follow the instructions for use, including proper cleaning and setup protocols to reduce the potential for burns.
In the past five years, Megadyne has distributed more than 27,000 reusable Mega Soft pads globally that have been used in more than 100 million surgical procedures.
The company is continuing to investigate the root cause of the burns.
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