Megadyne Medical Products, Inc. has initiated a recall of its Mega Soft Universal Patient Return Electrode, Mega Soft Universal Dual, Mega Soft Universal Plus, and Mega Soft Universal Plus Dual due to reported incidents of patient burns during surgeries involving electrosurgical instruments. Classified as a Class I recall by the U.S. Food and Drug Administration (FDA), this recall signifies the highest level of concern, as the use of these devices may lead to serious injuries or even death.
• Product Names: Megadyne Mega Soft Universal, Megadyne Mega Soft Universal Dual, Megadyne Mega Soft Universal Plus & Megadyne Mega Soft Universal Plus Dual
• Product Codes: GEI
• Model Numbers: 0845, 0846, 0847, 0848
• Distribution Dates: October 1, 2021, to December 4, 2023
• Devices Recalled in the U.S.: 9428
• Date Initiated by Firm: December 8, 2023
The Mega Soft Universal Patient Return Electrode is a critical medical device used in surgeries employing electrosurgical instruments. Its primary function is to establish a secure return path for the electrical current used in these procedures, ensuring patient safety. By facilitating the safe flow of current through the patient’s body back to the electrosurgical unit, the electrode minimizes the risk of electrical burns, a crucial safety measure in electrosurgery to prevent concentrated electrical energy in one area of the body.
Reason for Recall
Megadyne Medical Product, Inc. is recalling the Mega Soft Universal Patient Return Electrode family to update the Instructions for Use and product labeling. The aim is to restrict the use of the device to patients aged 12 years and older. The recall was prompted by reported cases of patient burn injuries, including third-degree burns requiring medical intervention. Severe burns may result in extended hospital stays, scarring, and additional surgeries, with potentially long-lasting impacts, especially in patients under the age of 12.
Actions for Users
Customers who have been affected by this recall have received an URGENT medical device correction notice from Megadyne Medical Products, Inc. The notice instructs users to:
1. Share the updated information with all users of Mega Soft Universal and Universal Plus pads, confirming that the intended use is now restricted to patients aged 12 years and older.
2. Post a copy of the communication to remind staff not to use the Mega Soft Universal and Mega Soft Universal Plus pads on patients under 12 years old.
3. Contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266) if medical engagement with the manufacturer is required.
4. Complete the Business Reply Form included in the letter and fax or email it to Sedgwick within three business days.
5. Continue following the current Mega Soft Instructions for Use, except for the new limitation in the population of intended use.
• Adults and children undergoing electrosurgery that utilizes MEGA SOFT Universal Reusable Patient Return Electrodes (not for use on children who are 12 years old or younger).
• Health care providers using Megadyne Mega Soft Universal Patient Return Electrode for monopolar electrosurgery or caring for patients after surgeries involving these electrodes.
Customers in the U.S. with questions about this recall should contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).