Usage of MEGA 2000 and MEGA SOFT devices manufactured by Megadyne, a subsidiary of Johnson & Johnson, may result in severe injuries or fatalities, warns FDA.
On Tuesday, the US Food and Drug Administration (FDA) escalated the recall status of specific electrosurgical instruments produced by a subsidiary of Johnson & Johnson (JNJ.N), to its highest severity level, indicating that their utilization could potentially cause harm or even death.
The federal healthcare oversight authority confirmed receipt of injury reports concerning both pediatric and adult patients. These injuries, specifically burns, were caused by the operation of the tools, marketed as MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes.
These devices, which are soft pads, function by transmitting an electrical charge through the patient’s body while performing electrosurgical operations. Their purpose is to generate heat or cut tissue, or to arrest bleeding during surgical procedures.
The recall was initiated by Megadyne Medical Products, a company bought by Ethicon Endo-Surgery, a J&J MedTech subsidiary, in 2017.
According to the FDA’s statement, Megadyne has received 63 injury reports connected to the devices’ use, although no fatalities have been reported. The company is currently investigating the primary causes of these burn injuries.
In the course of the probe into the burn injuries related to the devices, J&J MedTech found that the products were misused in certain cases.
The company reiterated that these products are still in circulation, and it had disseminated notifications in June, advising healthcare professionals to strictly adhere to the proper usage guidelines.
In June 2023, Megadyne began the recall process of 21,200 units of these electrosurgical tools, which had been distributed from March 11, 2021, to May 9, 2023, the regulator noted.
If you or a loved one suffered injuries caused by this dangerous product, you or your loved one could receive substantial financial compensation.
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