Electrode Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric Burns | FDA

UPDATES:

Starting in September 2024, Megadyne communicated in a letter to new and existing customers reiterating the use of affected devices in patients aged 12 years and older. Additionally, Megadyne's letter informs customers that the eIFU of devices indicates that no additional materials should be placed between the patient and Mega Soft pad (example: no sheet).

The devices listed below are included in the FDA’s “Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes - Letter to Health Care Providers” issued on July 31, 2024.

This recall involves updating instructions for using these devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Figure 1: Megadyne MEGA SOFT Patient Return Electrode

Figure 2: Megadyne MEGA 2000 Patient Return Electrode

On June 17, 2024, Megadyne sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:

Megadyne is correcting the MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Patient Return Electrodes after receiving reports of patient burn injuries, especially in children under 12 years of age, after procedures where the MEGA 2000 and MEGA SOFT Patient Return Electrodes were used.

The use of affected product may cause serious adverse health consequences for patients, including third-degree burns, scarring, and additional surgeries.

There have been 15 reported injuries. There have been no reports of death.

MEGADYNE MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 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.

Customers in the U.S. with questions about this recall should contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

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.

09/23/2024