Mega 2000™ and Mega Soft™ Patient Return Electrodes - Potential Risk of Patient Burn Injuries

Issue

Megadyne has received reports of patient and healthcare professional burns during or after surgical procedures in which Mega 2000 and Mega Soft Patient Return Electrode pads were used. Megadyne, in collaboration with Health Canada, has been taking corrective actions to mitigate the potential health risk to healthcare professionals and patients, particularly focusing on children under 12 years of age. Audience Healthcare professionals including surgeons, technologists, nurses and other healthcare professionals who are involved in electrosurgeries, setup and cleaning of the Megadyne™ Mega 2000 and Mega Soft Patient Return Electrodes in hospitals. Key messages Since June 2023, Megadyne has initiated 4 voluntary recalls of Mega 2000 and Mega Soft Patient Return Electrode pads due to reports of burn injuries in pediatric and adult patients, as well as healthcare professionals. The reports of patient 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 those under the age of 12 years. Healthcare professionals are advised of the following: Do not use Mega Soft Universal (Pediatric) Patient Return Electrode pads in any age group (see Table 1 in the Products affected section). Only use Mega Soft Universal, Mega 2000 or Mega Soft Patient Return Electrode pads on patients aged 12 years and older (see Table 2 in the Products affected section). Health Canada is working with Megadyne to update the instructions for use (IFU) for all affected product codes. Health Canada continues to assess the risk of thermal injury, and will take appropriate and timely action when new information becomes available. Background Mega 2000 and Mega Soft Patient Return Electrode pads are used during monopolar electrosurgery. The return electrode pads conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units or generators. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. These devices are not intended for radiofrequency ablation. The Mega Soft pads are intended to be used as 24-month reusable patient return electrodes. The Mega 2000 pads are intended to be used as 18-month reusable return electrodes. Since June 2023, Megadyne has initiated 4 voluntary recalls related to reports of healthcare professionals, and pediatric and adult patient burn injuries from use of these devices. The reports of patient burn injuries include third-degree burns, 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. Mega Soft Universal (Pediatric) Patient Return Electrode pad (product code 0840) should no longer be used and is being removed from the market. This pediatric pad was designed for patients only up to 22.7kg, which would be predominantly patients younger than the age of 12 (see Table 1 in the Products affected section and Appendix 1). The Mega 2000 and Mega Soft Patient Return Electrode pads should only be used on patients 12 years and older (see Table 2 in the Products affected section and Appendix 2). Information for healthcare professionals Healthcare professionals are advised of the following: Be aware that Mega Soft Universal (Pediatric) Patient Return Electrode pads, product code 0840, should NOT be used in any age group (see Table 1 in the Products affected section and Appendix 1). Be aware of the update to the IFU to change the intended use population to patients 12 years and older for all Mega 2000 and Mega Soft Patient Return Electrode pads (product codes: 0800, 0830, 0835, 0845, 0846, 0847, and 0848) even though these devices currently have labelling of “>25 lbs (>11.3 kg)” or “>0.35 kg (>0.8 lb)” on the pads (see Table 2 in the Products affected section and Appendix 2). Continue following the IFU for Mega 2000 and Mega Soft Patient Return Electrode pads for proper cleaning, placement, and setup steps for the pads. Follow patients post-operatively in the usual manner after procedures involving the use of Mega 2000 and Mega Soft pads. Action taken by Health Canada Health Canada, together with the U.S. Food and Drug Administration (FDA), is raising awareness among healthcare professionals and facilities about the safe use of Mega 2000 and Mega Soft Patient Return Electrode pads. Health Canada continues to evaluate the risk of thermal injury associated with the use of these devices. If new risk information becomes available, we will take appropriate and timely action to mitigate the risk to Canadians. Health Canada is communicating this important safety information to Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians website. This communication will be further distributed through the MedEffect™ e-Notice email notification system. Report health or safety concerns Managing marketed health product-related side effects and incidents depends on healthcare professionals and consumers reporting them. Any case of burns or other serious or unexpected incident in patients using Mega 2000 and Mega Soft Patient Return Electrode pads should be reported to Megadyne or Health Canada. Megadyne, a business unit of Johnson and Johnson MedTech 200 Whitehall Dr, Markham, ON, L3R 0T5 Telephone: 1-800-872-3080 Fax: 905-946-2050 To correct your mailing address or fax number, contact Megadyne. You can report a medical device problem to Health Canada at: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/medical-device.html For other medical device inquiries related to this communication, contact Health Canada at: Regulatory Operations and Enforcement Branch E-mail:meddev-matmed@hc-sc.gc.ca Original signed by Inga Brencis Director Commercial Quality Canada Megadyne, a business unit of Johnson and Johnson MedTech Appendix 1 - Mega Soft Universal (Pediatric) Patient Return Electrode pads (0840), which were designed for patients only up to 22.7kg, have been recalled and removed from healthcare facilities and should NOT be used. Appendix 2 – Current on-device labelling Mega 2000 (0800) Mega Soft (0830) Mega Soft (0835) Mega Soft Universal (0845) Mega Soft Universal (0846) Mega Soft Universal Plus (0847) Mega Soft Dual Universal Plus (0848)

What you should do

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