US FDA classifies recall of J&J Electrosurgical Tools as most serious - The U.S. Food and Drug Administration (FDA) on Tuesday categorized a recall for specific electrosurgery instruments produced by the Johnson & Johnson unit (JNJ.N) as "most serious" and warned that the use of these tools could result in deaths or injuries.
July 13, (The Justice Now) – A U.S. health regulator said it received reports of adults and children suffering burn injuries due to the devices, available by the brands MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes, applied to them.
The instruments are soft pads that transmit an electric charge through the patient’s body in electrosurgical procedures to warm or cut tissue or stop bleeding.
The devices were taken back from Megadyne Medical Products, purchased at the beginning of 2017 through Ethicon Endo-Surgery. It is a division that is part of J&J MedTech.
Megadyne was notified of 64 injuries but no deaths resulting from the use of its devices. The FDA declared in a press release that it is also continuing to determine the burns that patients suffer.
J&J MedTech said during the examination of burn injuries due to the device’s use, it was discovered that, in certain instances, the machines were not utilized correctly.
The company claimed they are still available and sent out notifications in June to health personnel to ensure they follow the proper guidelines for their use.
The regulator stated that Megadyne, on June 20, 2023, started the recall that included 21,200 pieces of electrosurgery instruments that were distributed between March 11, 2021, to May 9, 2023.
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