Source: Home of Instruments
On May 10, 2024, the U.S. Food and Drug Administration (FDA) said that Megadyne, a Johnson & Johnson company, voluntarily recalled its ultra-soft reflux electrodes for pediatric patients and stopped using the product.
Megadyne withdrew the product after reports of patient burns during the use of the electrodes. Root cause investigations include tests that show potential thermal damage when multiple factors coexist.
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Recall and discontinuation of production
On May 10, 2024, Megadyne is voluntarily recalling all MEGA DYNE MEGA SOFT pediatric patient reflux electrodes. The product was removed from the shelves because Megadyne received reports of patient burns while using the Mega Soft Patient Reflux Electrode. Investigation of the root cause of the report includes testing, which has shown that the presence of multiple factors may lead to potential thermal damage.
A combination of these conditions is more likely to occur when spacers are used for infants and toddlers. Because the Children's Store is designed for patients weighing between 0.8 and 50 pounds, primarily those under the age of 12, it has been decided to discontinue and recall the 0840 Children's Pads product.
From 2018 to today, there have been 4 reported injuries related to this product and no fatalities reported. The company has decided to discontinue and voluntarily recall the MEGA dyne MEGA SOFT pediatric patient return electrode. FDA has been notified of this.
Customers who have the MEGA dyne MEGA SOFT pediatric patient reflux electrode should discontinue use and return it.
Megadyne is notifying customers and distributors worldwide by mail and arranging for the return of affected products. Products are sold in the United States and international markets.
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Multi-order callings
Previously, there have been multiple recalls of related products.
2024 First Year Call
On January 9, 2024, the U.S. Food and Drug Administration (FDA) issued a notice "Regarding the Emergency Medical Device Correction for Megadyne by Johnson & Johnson," listing it as a Class I recall. It is important to note that this action is classified as a corrective rather than a complete product withdrawal.
It is reported that the recall was taken after receiving reports of burns that could cause significant harm to children, involving 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 spacers are critical components used in surgeries involving electrosurgical instruments and are designed to avoid the risk of burns to patients by providing a safe loop for the currents used in these procedures, preventing energy from being concentrated in specific areas of the patient's body.
In the Notice of Correction, Megadyne adjusted the limits for the use of Mega Soft Universal and Universal Plus Reusable Patient Reflux Electrode Spacers to patients 12 years of age or older; The Mega Soft Pediatric Pediatric Reusable Patient Reflux Electrode Spacer (for patients weighing between 0.8 pounds and 50 pounds) is not affected by this correction and can continue to be used.
Megadyne initiated the recall on Dec. 8 involving 9,428 devices distributed between Oct. 1, 2021 and Dec. 4, 2023. Megadyne has received 99 reported injuries so far, but fortunately no fatalities have been reported.
2023 call-up
It's important to note 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 that time, Megadyne had already received 63 reports of injuries related to its eight Mega Soft electrode products.
In its initial review, Megadyne said that some of the burn cases were related to the provider's failure to follow the instructions for use, but the company failed to locate design or manufacturing defects and did not confirm the root cause.
In a letter to customers, the company stated: "Instructions for the use of the Mega Soft pad include proper setup steps, such as the Mega Soft pad must be rinsed thoroughly after cleaning to ensure that there is no residue of the cleaning solution. 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 result in burns to the patient. ”
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The surgeon founded the company and Johnson & Johnson acquired
According to the data, Megadyne is a medical device company founded in 1985, headquartered in the United States, focusing on the design, manufacture and sales of medical devices and tools for electrosurgery. Electrosurgery is a surgical procedure that uses an electric current to heat or cut tissue and stop bleeding.
The founder of the company was G. G. Murphy, a well-known ear, nose and throat surgeon in Salt Lake City, Utah. Dr. Marsden Blanch, Megadyne was founded to address the problem of eschar build-up on electrocoagulation blades, a common problem experienced by all surgeons, and cleaning these scabs often costs 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 scorching, and in doing so, created the E-Z Clean electrocoagulation blade, successfully solving this challenge and changing the standard of care in the operating room.
JOHNSON & JOHNSON ACQUIRES MEGADYNE
On January 20, 2017, Johnson & Johnson's subsidiary, Megadyne Medical, announced the successful completion of the acquisition of Megadyne Medical.
Megadyne's world-class product portfolio, including monopolar and bipolar electrodes, patient return electrodes, generators, and smoke removal systems, provides a powerful addition to Chercon's advanced energy tools. This will not only strengthen Ethcon's position in the global energy market, but will also provide more options for the hospital system and surgeons, benefiting more patients.
MEGADYNEE-Z Clean电凝刀片
The E-Z Clean electrocoagulation blade has a unique non-sticky polytetrafluoroethylene (PTFE) coating that allows surgeons to easily remove any crust buildup or debris during surgery using just a sponge or sterile gauze pad.
Currently, MEGADYNE has developed a complete line of electrocoagulation blades in a variety of sizes, shapes, and configurations to suit a variety 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 to this, the company also manufactures patient reflux electrodes, which are critical components used in surgeries involving electrosurgical instruments and are designed to avoid the risk of burns by providing a safe loop for the currents used in these surgeries, preventing energy from being concentrated in specific areas of the patient's body.
MEGADYNE MEGA SOFT电极垫片
THE MEGADYNE MEGA SOFT IS DESIGNED TO PREVENT EXCESSIVE CONCENTRATION OF CURRENT, REDUCING HEAT BUILD-UP AND THUS MINIMIZING THE LIKELIHOOD 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 isolation electrosurgical generators.
MEGADYNE MEGA SOFT IS MORE ENVIRONMENTALLY FRIENDLY THAN TRADITIONAL ADHESIVE PATIENT REFLUX ELECTRODES, REUSABLE FOR UP TO 24 MONTHS, REDUCING WASTE TO A GREAT EXTENT. In addition, the product features a glue-free design that eliminates tape-related patient injuries and is latex-free for an increased level of patient protection.
MEGADYNE MEGA SOFT is available in a variety of models for adult surgical 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 0.35 kg (0.8 lbs), there is no maximum weight limit. Compared to the original MEGA SOFT pad, the MEGA SOFT Universal is lighter, making it easier to position and carry the pad.
- Mega Soft combines MEGA SOFT patient reflux electrode technology with operating room and table pressure relief pads, allowing it to be used in a variety of surgical procedures and situations.
- The Mega Soft Pediatric is designed for patients weighing between 0.35 kg and 22.7 kg (0.8 lbs and 50 lbs). Equipped with a stress-relieving polymer material and adhesive-free material, it protects delicate skin.
Energy surgical instruments refer to the instruments that use electrical energy (electrosurgery) or mechanical energy (ultrasound surgery) to separate, cut, coagulate, and stop bleeding of tissues during surgical operations, mainly including plasma knife, ultrasonic knife, high-frequency electric knife, etc.
According to Frost & Sullivan's research data, the global surgical energy device market will reach $9.099 billion in 2022 and is expected to reach $13.066 billion in 2028, with a compound annual growth rate (CAGR) of 6.2%.
Multinational companies dominated by Johnson & Johnson and Medtronic are major players in this field and occupy the core position of the market. The home of equipment will continue to pay attention.