The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
On July 21, 2023, the FDA updated this communication to correct the recommended actions for customers. This recall is a voluntary correction, not a product removal. Customers should follow the recommended actions described below.
- Product Names and Codes:
- MEGADYNE MEGA 2000 Patient Return Electrode 0800
- MEGADYNE MEGA SOFT Reusable Patient Return Electrode 0830
- MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode 0835
- MEGADYNE MEGA SOFT Pediatric Patient Return Electrode 0840
- MEGADYNE MEGA SOFT Universal Patient Return Electrode 0845
- MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode 0846
- MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode 0847
- MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode 0848
- Devices Recalled in the U.S.: 21,200
- Dates Distributed: March 11, 2021 – May 9, 2023
- Date Initiated by Firm: June 1, 2023
MEGA 2000 (Figure 1) and MEGA SOFT (Figure 2) Reusable Patient Return Electrodes are soft pads used during electrosurgery. In electrosurgery, an electric current is used to heat or cut tissue or to stop bleeding. The electric current is generated by an electrosurgical generator and delivered to the tissue with a small pen-like attachment. A return electrode pad contacts the skin of the laying patient during use and conducts the electric current from the patient's tissue back to the electrosurgical unit, or generator, to reduce the risk of excessive heating.
Reason for Recall
Megadyne is recalling MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes after receiving reports of patients receiving burn injuries from use in both pediatric and adult patients. These burns may be as serious as third-degree burns requiring medical intervention and may lead to a longer hospital stay, scarring, and potentially more surgeries for pediatric and adult patients. Megadyne is continuing to evaluate the root cause for patient burns.
Use of affected products may cause serious injury or death.
Megadyne reports 63 injuries and no deaths related to this issue. If additional actions are necessary to further help ensure the safe use of these devices, Megadyne will notify customers.
Who May Be Affected
- Adults and children undergoing electrosurgery that uses MEGA 2000 or MEGA SOFT Reusable Patient Return Electrodes.
- Health care providers who use MEGA 2000 or MEGA SOFT Reusable Patient Return Electrodes to perform monopolar electrosurgery or who care for patients after surgeries that use these electrodes.
On June 1, 2023, Megadyne sent an Urgent Medical Device Correction letter to customers that included the following recommended actions:
- Share the notification with all users involved in MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes cleaning, operating room and patient setup, and device operation during procedures.
- Confirm that personnel using the MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes are following the instructions for use as shown in the letter and available at: https://www.eifu.com.
- Post the "Cleaning and Care Visual Aid and Placement and Setup Visual Aid," both included as attachments to the letter, near the operating room to remind staff about instructions for cleaning and setup.
- Contact any facilities where products may have been shared.
- Complete the Business Reply Form attached to the letter.
- Fax the form to 888-214-7430 or email it to Sedgwick at Ethicon5627@sedgwick.com within three (3) business days.
- For additional copies of this communication or questions about returning the Business Reply Form, contact Sedgwick at 888-843-0254 and reference Event # 5627.
- If medical engagement with manufacturer is requested, health care providers should submit the request using the Medical Information Request website: https://www.jnjmedtech.com/mir.
The letter also noted that health care providers who have used MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes during patient procedures should follow patients post-operatively in the same way with no additional action required related to the correction.
Customers with questions about this recall should contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.