Megadyne removed the product last month after reports of patient burn injuries in procedures that used the electrodes. A root cause investigation included testing that showed a combination of factors that, when present together, may result in the potential for thermal injuries.
Last year, the company recalled a number of Megadyne Mega Soft electrodes and the Mega 2000 electrodes, manufactured by J&J’s Ethicon. At the start of this year, the FDA deemed another recall of Mega Soft electrodes as Class I, the most serious kind. These recalls all related to reports of patient burn injuries, including third-degree burns requiring intervention.
An FDA notice confirms the need for the removal of the Mega Soft pediatric electrodes (product code 0840). Providers should stop using them and return them to Megadyne.
The electrodes contact the skin of the laying patient during electrosurgery, conducting the current from the patient’s tissue back to the electrosurgical unit, or generator, to reduce the risk of excessive heating.
The FDA says the use of affected product may cause adverse health consequences for pediatric patients. That could include third-degree burns, scarring and additional surgeries. Megadyne reports four injuries and zero deaths related to the issue.
Megadyne says the combination of the conditions causing the issue may be more likely when the pad is used with infants and small children. Because Megadyne designed the pediatric pad for patients between 0.8 and 50 pounds, that extends to predominantly patients under 12. That led to the decision to discontinue and recall the 0840 pediatric pad product.
