601-769-1440

sandslawms@gmail.com

CALL US
CONTACT US

Megadyne Mega Electrode Recalls

Weitz & Luxenberg is accepting cases from clients who suffered burns after they, or a loved one, under- went an electrosurgical procedure using Megadyne Mega 2000 or Mega Soft Patient Return Electrodes. Megadyne’s “patient return electrodes are used during monopolar electrosurgery.”

These devices are used during surgeries. If you were badly burnt and injured by this defective medical device, contact our attorneys now. We can help you get any financial compensation you may deserve.
Since June of last year, Megadyne has initiated four recalls voluntarily. Reports indicate pediatric and adult patients, as well as health care providers, have experienced burn injuries. In some cases, people experi- enced burns that required intervention. Getting these significant burns means patients needed to spend a long time in the hospital, experienced permanent scarring, and had to undergo additional surgeries.

The U.S. Food & Drug Administration (FDA) has not yet classified this recall. However, the FDA has issued a Letter to Health Care Providers outlining how to safely use the devices, including to not use one of the products at all, as described below.

Z

Using Mega 2000 and Mega Soft Patient Return Electrodes Safely

Both the FDA and Health Canada have advised health care providers to follow these safety instructions:

  • Do not use Mega Soft Pediatric Patient Return Electrodes (product code 0840) in any age group.
  • Only use Mega 2000 and Mega Soft Patient Return Electrodes (product codes: 0800, 0830, 0835, 0845, 0846, 0847, and 0848) on patients 12 years and older.
  • Monitor patients post-operatively after procedures using Mega 2000 and Mega Soft pads.
Z

Using Mega 2000 and Mega Soft Patient Return Electrodes Safely

According to the FDA, patient return electrodes conduct “monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units or generators.” Use of electrosurgical units must be used with isolated monopolar electrosurgical generators. They are in no way intended for radiofrequency ablation.

In addition, “Mega Soft are intended to be used as 24-month reusable patient return electrodes. Mega 2000 are intended to be used as 18-month reusable patient return electrodes.”

Megadyne’s Patient Return Electrodes are “lightweight, pressure reduction” pads. of varying thick- nesses. Current is meant to flow from a patient to the pressure reduction pad. Ideally, the pad prevents “high current concentration build up at the pad site.” In the operating room, these pads are meant to protect patients from high current concentration of electricity.

Z

Megadyne Electrodes in Electrosurgery

Electrosurgery is often used during a surgical procedure “to control bleeding and to rapidly dissect soft tissue. The electrical resistance of these soft tissues to an electromagnetic current generates heat. The endpoints of electrosurgery vary based on the waveform, power used, and surgical technique. This results in a variety of effects on the target tissue.”

Electrosurgery is common. A variety of medical specialties use the technique of electrosurgery, including dermatology, gynecology, urology, and neurology. Electricity is converted to heat. The surgeon can cut through soft tissue, as well as cauterize it.

Z

FDA Monitoring Megadyne Electrodes

The FDA is working to ensure health care providers and facilities are fully notified of the recall instructions. Updated labeling for affected products is possible.

The agency also continues to keep an eye on device performance and additional reports of burns. According to the FDA, “reports of burns include up to third-degree burns requiring intervention, which may lead to prolonged hospital stay, scarring, and additional surgeries. Burn injuries may lead to long-lasting impacts on patients, especially under the age of 12 years.”

If your clients suffered severe burns during an electrosurgical procedure, please consider referring these cases to W&L.