The US Food and Drug Administration (FDA) has issued a Class I product recall notice for Megadyne’s MEGA 2000 and MEGA Soft reusable patient return electrodes due to the risk of serious burns to patients. Use of the devices may cause serious injury or death.
The electrodes are manufactured by Johnson & Johnson’s Ethicon.
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MEGA 2000 and MEGA Soft reusable patient return electrodes are soft pads used during electrosurgery, during which an electric current is used to heat or cut tissue or to stop bleeding. The electric current is generated and delivered to the tissue with a small pen-like electrosurgical generator. During electrosurgery, a return electrode pad contacts the skin and conducts the electric current from the patient’s tissue back to the electrosurgical unit and lowers the risk of excessive heating.
Ethicon expanded its Megadyne Mega Soft portfolio of reusable patient return electrodes in September 2019, which it then claimed was used in more than 100 million procedures across the world. There were 21,200 Devices Recalled in the US. The devices were distributed between 11 March 2021 and 9 May 2023, with the recall initiated on 1 June 2023.
The recall was issued after reports of both paediatric and adult patients receiving burn injuries. In some cases, these were third-degree burns requiring medical attention and possibly leading to a longer hospital stay, scarring, and potentially more surgeries.
Megadyne is continuing to evaluate the root cause of patient burns. It has reported 63 injuries, but no deaths related to the issue. Megadyne will notify customers if further actions are necessary to use the devices safely.
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By GlobalDataOn June 1, 2023, Megadyne sent an urgent medical device correction letter to customers that was shared with all users involved in cleaning, operating room and patient setup, and device operation during procedures.
The letter recommended that users confirm they are following the instructions for use shown in the letter and that they 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 stated that patients should be followed post-operatively in the same way as usual with no additional action required related to the correction.
A representative from Johnson & Johnson MedTech gave Medical Device Network the following statement:
“At MEGADYNE, our first priority is to our customers and their patients, and that includes the safe and effective use of our products. 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.”
“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 product’s labelling, are a safe alternative to disposable return electrodes.”
“Mega Soft pads have been used in more than 100 million surgical procedures. In the past five years, more than 27,000 reusable Mega Soft pads have been in use globally.”
The recall did not have an immediate impact on Johnson & Johnson’s share price which rose by 3.1% at market open July 12.
