FDA: Johnson & Johnson discontinued use of this product

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On May 10, 2024, the U.S. Food and Drug Administration (FDA) announced that Johnson & Johnson's Megadyne is voluntarily recalling its ultra-soft pediatric patient reflux electrode and discontinuing use of the product.

Megadyne withdrew the product after reports of burns in patients using the electrodes. Root cause investigations include tests that show potential heat damage when multiple factors are present together.

1. Recall and stop production

On May 10, 2024, Megadyne voluntarily recalled the reflux electrodes for all MEGA dyne MEGA SOFT pediatric patients. The product was removed because Megadyne received reports of patient burns during the use of Mega Soft patient reflux electrodes. The root cause investigation into the report includes tests that show a combination of factors can cause potential heat damage

A combination of these conditions is more likely to occur when spacers are used for infants and young children. Because the Children's Store is designed for patients weighing between 0.8 and 50 pounds, primarily those under the age of 12, the decision was made to discontinue production and recall the child pad product with ID number 0840.

From 2018 to today, there have been four reports of injuries associated with the product and no reported deaths. The company has decided to discontinue and voluntarily recall the MEGA dyne MEGA SOFT pediatric patient return electrodes. FDA has been notified.

Customers with the MEGA dyne MEGA SOFT pediatric patient reflux electrode should stop using it and return it.

Megadyne is notifying customers and distributors worldwide by email and arranging for the return of the affected products. Products are sold in the United States and international markets.

2. Multiple recalls

There have been multiple recalls of related products.

An early 2024 recall

The recall follows reports of burns that could cause significant injury to children and involves four patient reflux electrode products: Mega Soft Universal, Universal Dual, Universal Plus and Universal Plus Dual.

According to the FDA's recall notice, these electrode shims are a critical component used in procedures involving electrosurgical instruments and are designed to avoid the risk of burns to patients by providing a safety loop for the currents used in these procedures, preventing energy from concentrating in specific areas of the patient's body.

In the correction notice, Megadyne adjusted the restrictions on the use of the Mega Soft Universal and Universal Plus reusable patient reflux electrode gaskets to patients 12 years of age or older; Mega Soft Pediatric reusable patient reflux electrode gaskets (for patients weighing between 0.8 and 50 pounds) are unaffected by this correction and can continue to be used.

Megadyne initiated the recall on Dec. 8, covering 9,428 devices distributed between Oct. 1, 2021, and Dec. 4, 2023. Megadyne has received 99 reports of injuries, but fortunately no deaths.

2023 Recall

It's worth noting that this isn't the first time Megadyne has faced such an incident. In 2023, the company recalled several Megadyne Mega Soft electrodes and Mega 2000 electrodes due to similar issues.

In June 2023, Megadyne issued an emergency safety notice warning users about the risk of burns, followed by a Level 1 notice from the FDA in July. At the time, Megadyne had received 63 reports of injuries related to its eight Mega Soft electrode products.

In an initial review, Megadyne stated that some of the burn cases were related to the supplier's failure to follow instructions, but the company was unable to find a design or manufacturing defect and did not identify a root cause.

In a letter to customers, the company said: "The instructions for the use of the Mega Soft pad include appropriate setup steps, such as the Mega Soft pad must be fully rinsing after cleaning to ensure that there is no residue of the cleaning solution." Failure to follow the "Instructions for use" of the Mega Soft pad may result in burns to the patient if the residue of the cleaning solution is not rinsed off properly."

3. Surgeon founded and acquired by Johnson & Johnson

Megadyne is a medical device company founded in 1985 and headquartered in the United States that focuses on the design, manufacture and sale of medical devices and tools for electrosurgery. Electrosurgery is a surgical procedure that uses electrical current to heat or cut tissue and stop bleeding.

Founded by Dr. G. Marsden Blanch, a renowned ear, nose and throat surgeon in Salt Lake City, Utah, Megadyne was originally founded to solve the problem of eschars building up on electrocoagulation blades, a common problem experienced by all surgeons, and the removal of these scabs often delays valuable surgical time.

To solve this problem, with the help of several biomedical engineers, Dr. Blanch developed a high-tech coating process that, when applied to stainless steel electrodes, makes them resistant to coking, and in doing so created the E-Z Clean electrocoagulation blade, which successfully solved this challenge and changed the standard of care in the operating room.

Johnson & Johnson acquires MEGADYNE

On January 20, 2017, Ethicon, a subsidiary of Johnson & Johnson Group, announced that it had successfully completed the acquisition of Megadyne Medical.

Megadyne complements Ethicon's advanced energy tools with its world-class product portfolio, including unipolar and bipolar electrodes, patient return electrodes, generators and smoke removal systems. Not only does this strengthen Ethicon's position in the global energy market, it will also provide more options for hospital systems and surgeons to benefit more patients.

MEGADYNEE-Z Clean electrocoagulation blade

The E-Z Clean electrocoagulation blade has a unique non-adhesive polytetrafluoroethylene (PTFE) coating that allows the surgeon to easily remove any crusted buildup or debris during surgery using only a sponge or sterile gauze pad.

MEGADYNE has developed a complete line of electrocoagulation blades in a variety of sizes, shapes and configurations to suit a wide range of surgical needs. These include standard blade electrodes, disinfectant blade electrodes, precision blade electrodes, and a range of disposable electrodes that can be used in laparoscopic surgery.

In addition, the company manufactures patient reflux electrodes, which are key components used in surgeries involving electrosurgical instruments and are designed to avoid the risk of patient burns by providing a safety loop for the currents used in these surgeries, preventing energy from concentrating in specific areas of the patient's body.

MEGADYNE MEGA SOFT electrode gasket

MEGADYNE MEGA SOFT is designed to prevent excessive concentration of current and reduce heat buildup, thereby minimizing the possibility of burns at the surgical pad site. To date, the product has been used in more than 100 million surgeries and is compatible with most mainstream isolated electrotome generators.

MEGADYNE MEGA SOFT is more environmentally friendly than traditional paste patient reflux electrodes and can be reused for up to 24 months, greatly reducing waste. In addition, the product features a glue-free design that eliminates tape-associated patient harm and is latex free, increasing the level of patient protection.

MEGADYNE MEGA SOFT is available in a variety of models for adult surgery and pediatric patients.

The Mega Soft Universal is a universal model that is suitable for patients of any size. Because the product is designed for patients over 0.35kg(0.8 lb), there is no maximum weight limit. Compared to the original MEGA SOFT pad, the MEGA SOFT Universal is lighter and easier to position and carry the gasket.

Mega Soft combines MEGA SOFT patient reflux electrode technology with the operating room operating table pressure relief pad, making it applicable to a wide range of surgical procedures and Settings.

Mega Soft Pediatric is designed for patients weighing between 0.35 kg and 22.7 kg (0.8 lb to 50 lb). Equipped with pressure-reducing polymer material and no adhesive, it can effectively protect delicate skin.

Energy surgical instruments refer to instruments that use electrical energy (electrosurgery) or mechanical energy (ultrasonic surgery) to separate, cut, coagulate, hemostasis and other operations on tissues during surgical operations, mainly including plasma knife, ultrasonic knife, high-frequency electroknife, etc.

According to Frost & Sullivan research data, the global surgical energy device market size reached 9.099 billion US dollars in 2022, and is expected to reach 13.066 billion US dollars in 2028, with a compound annual growth rate (CAGR) of 6.2%.

Johnson & Johnson, Medtronic (Medtronic) mainly multinational enterprises are the main players in this field, occupy the core position of the market, Johnson & Johnson to withdraw the product, will it affect the layout of the relevant product line? Equipment home will continue to pay attention.