Megadyne Electrosurgery Electrodes Recall Issued Due to Burn Injuries, Patient Deaths
Medical device manufacturer Megadyne, a subsidiary of Johnson & Johnson, has issued a recall for their electrosurgery electrodes, due to a risk of serious burns, following dozens of reports of involving injuries sustained after using the devices.
The U.S. Food and Drug Administration (FDA) announced the Megadyne recall on June 1, giving it a Class I medical device recall designation, and warning health care professionals that consumers face an increased risk of suffering serious burn injuries or death with continued use.
According to the recall notice, the manufacturer has become aware of electrical burns in both pediatric and adult patients during use of the medical tools, which have resulted in severe third degree, or full-thickness, burns requiring medical attention or hospitalization. Officials warn the burn risks may lead to a longer hospital stay, scarring, and potentially more surgeries for patients.
Electrosurgical patient electrodes are tools used by health care professionals during electrosurgical procedures to disperse and remove electrical current away from the patient and back to the electrosurgical unit to reduce excessive heat and prevent burn injuries.
The adhesive electrode pads are applied directly to a patient’s skin and assist health care professionals in making precise cuts to remove soft tissue while limiting blood loss. However, officials warn that in the event of poor electrical circulation within the electrode pad, electricity can concentrate on one area of a patient’s body and result in an electrical burn.
Megadyne has received at least 63 reports related to the issue since April 2018, with several injuries resulting in third degree burns that required medical intervention, hospitalization or additional surgeries to treat.
While the medical device manufacturer believes some of the reported patient burn injuries may have resulted from improper use of the devices such as not thoroughly cleaning them after use, they are still investigating the root cause of the issue.
The recall impacts approximately 21,200 Megadyne MEGA 2000 and MEGA SOFT reusable patient return electrode pads distributed from March 11, 2021 through May 9, 2023.
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Megadyne sent an urgent medical device correction letter notifying customers of the issue on June 1, which explained the problems with the devices and provided detailed instructions for device operation and procedures. In addition, the manufacturer also supplied cleaning instructions which should be posted near any operating rooms, as well as a business reply form for customers complete.
Customers should send their completed business reply forms within three business days by fax to 888-214-7430, or email Ethicon5627@sedgwick.com.
For more information on the recall, or to request additional copies of any recall communications, customers may call Sedgwick at 888-843-0254 and reference event number 5627. They may also contact the resource department of Ethicon, Megadyne’s parent company at 1-877-ETHICON (1-877-384-4266).
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