On May 10, 2024, the U.S. Food and Drug Administration (FDA) stated:Johnson & Johnson's Megadyne Medical Products, Inc. voluntarily recalls its ultra-soft pediatric patient return electrodes and discontinues the use of the product.

Following reports of patient burns during the use of electrodes, Megadyne Medical Products, Inc. withdrew the product. The root cause investigation included tests showing that potential thermal injury could occur when multiple factors coexisted.

On May 10, 2024, Megadyne Medical Products, Inc. voluntarily recalled all MEGA dyne MEGA SOFT pediatric patient return electrodes.The product was removed from the market because Megadyne received reports of patient burns during the use of the Mega Soft patient return electrode.The root cause investigation of the report included testing, which showed that potential thermal damage could occur when multiple factors coexist.

When the pad is used for infants and toddlers, the combination of these conditions is more likely to occur. Since the pediatric store is designed for patients weighing between 0.8 and 50 pounds, primarily patients under the age of 12, it was decided to discontinue and recall the product with the identification code 0840, the pediatric pad.

From 2018 to today, there have been four injury reports related to this product and no death reports. The company has decided to stop and voluntarily recall the MEGA dyne MEGA SOFT pediatric patient return electrode. The FDA has been notified.

Customers who have MEGA dyne MEGA SOFT pediatric patient return electrodes should stop using them and return them.

Megadyne is notifying global customers and distributors by mail and arranging for the return of affected products. The products were sold in the U.S. and international markets.

Previously, related products have been recalled multiple times.

Recall at the Beginning of 2024

On January 9, 2024, the U.S. Food and Drug Administration (FDA) issued a"Correction of Emergency Medical Devices by Megadyne, a Johnson & Johnson Company"The announcement classified it as a Class I recall. Notably, this action is categorized as a correction rather than a full product withdrawal.

It is reported that this recall was initiated after receiving reports of burns that could potentially cause significant harm to children.Involving four patient return electrode products:Mega Soft Universal, Universal Dual, Universal Plus, and Universal Plus Dual.

According to the FDA's recall notice, these electrode pads are critical components used in surgeries involving electrosurgical instruments. They are designed to provide a safe circuit for the current used in these procedures, preventing energy from concentrating in specific areas of the patient’s body, thereby avoiding the risk of patient burns.

In the correction notice, Megadyne willThe use of Mega Soft Universal and Universal Plus reusable patient return electrode pads is restricted to patients aged 12 years or older.Mega Soft Pediatric Reusable Patient Return Electrode Pad (for patients weighing between 0.8 lbs and 50 lbs) is not affected by this correction and can continue to be used.

Megadyne initiated this recall on December 8, involving 9,428 devices distributed between October 1, 2021, and December 4, 2023.Currently, Megadyne Medical Products, Inc. has received 99 injury reports, fortunately, there have been no death reports.

2023 Recall

Notably, this is not 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.

June 2023,Megadyne Medical Products, Inc. has issued an urgent safety notice warning users about the risk of burns.In July, the FDA sent a Class I notification. At that time, Megadyne had received 63 injury reports related to its eight Mega Soft electrode products.

During the preliminary review, Megadyne stated that some burn cases were related to providers not following the operating instructions, but the company failed to identify any design or manufacturing defects and did not confirm the root cause.

The company stated in a letter to customers:"The instructions for use of the Mega Soft pad include appropriate setup steps, such as thoroughly rinsing the Mega Soft pad after cleaning to ensure no cleaning solution residue remains.""If the residue of the cleaning solution is not properly rinsed off, failure to follow the 'Instructions for Use' of the Mega Soft pad may cause patient burns."

Data shows,Megadyne is a medical device company established in 1985, headquartered in the United States, specializing in the design, manufacture, and sale of medical devices and tools for electrosurgical procedures.Electrosurgery is a surgical procedure that uses electric current to heat or cut tissue and stop bleeding.

The founder of the company is Dr. G. Marsden Blanch, a renowned ENT surgeon from Salt Lake City, Utah.Megadyne was founded to address the common issue of eschar buildup on electrosurgical blades, a problem that all surgeons encounter, and cleaning these deposits often wastes valuable surgical time.

To address this issue, 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. This led to the creation of the E-Z Clean electrosurgical blade, which successfully resolved this challenge and transformed the standard of care in operating rooms.

Johnson & Johnson Acquires MEGADYNE

On January 20, 2017, Ethicon, a subsidiary of Johnson & Johnson, announced the successful completion of the acquisition of Megadyne Medical Products, Inc.

Megadyne, with its world-class portfolio including monopolar and bipolar electrodes, patient return electrodes, generators, and smoke evacuation systems, provides a strong complement to Ethicon's advanced energy tools. This not only enhances Ethicon's position in the global energy market but also offers more choices to hospital systems and surgeons, benefiting more patients.

MEGADYNEE-Z Clean Electrosurgical Blade

E-Z Clean Electrosurgical Blade features a unique non-stick polytetrafluoroethylene (PTFE) coating, allowing surgeons to easily remove any eschar buildup or debris using only a sponge or sterile gauze pad during surgery.

Currently,MEGADYNE has developed a full range of electrocautery blades in various sizes, shapes, and configurations to meet diverse surgical needs.These include standard blade electrodes, disinfectant blade electrodes, precision blade electrodes, and a series of disposable electrodes that can be used for laparoscopic surgery.

In addition, the company also produces patient return electrodes, which are critical components used in surgeries involving electrosurgical instruments. These electrode pads provide a safe circuit for the current used in such surgeries, preventing energy from concentrating in specific areas of the patient’s body and thereby avoiding the risk of burns.

MEGADYNE MEGA SOFT Electrode Pad

MEGADYNE MEGA SOFT is designed to prevent excessive current concentration, reduce heat accumulation, and thereby minimize the possibility of burns at the surgical pad site.To date, the product has been used in over 100 million surgical procedures and is compatible with most mainstream electrosurgical generators.

Compared with traditional adhesive patient return electrodes, MEGADYNE MEGA SOFT is more environmentally friendly.It can be reused for up to 24 months.Greatly reduce waste. In addition, the product features a glue-free design, eliminating patient injuries associated with tape, and is latex-free, enhancing the level of patient protection.

MEGADYNE MEGA SOFT comes in various models, specifically designed for adult surgeries and pediatric patients.

• Among them, Mega Soft Universal is a universal style, suitable for patients of any body type. Since this product is specifically designed for patients weighing more than 0.35kg (0.8 pounds), it has no maximum weight limit. Compared with the original MEGA SOFT pad, the MEGA SOFT Universal is lighter and more convenient for positioning and carrying.

  
  

• Mega Soft combines MEGA SOFT patient return electrode technology with operating room table pressure-relieving pads, making it suitable for a variety of surgical procedures and settings.

  
  

• Mega Soft Pediatric is designed for patients weighing between 0.35 kilograms and 22.7 kilograms (0.8 pounds and 50 pounds).Equipped with pressure-reducing polymer materials and free of adhesives, effectively protecting delicate skin.

Energy-based surgical instruments refer to devices that utilize electrical energy (electrosurgery) or mechanical energy (ultrasound surgery) to perform operations such as tissue dissection, cutting, coagulation, and hemostasis during surgical procedures, mainly including plasma knives, ultrasonic scalpels, and high-frequency electrosurgical units.

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

Multinational companies such as Johnson & Johnson and Medtronic are the main players in this field, occupying a core market position.Will Johnson & Johnson's recall of its products this time affect the layout of related product lines? Instrument Family will continue to follow up.

END

 

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