Megadyne has recently received reports of 63 injuries (and counting) related to their MEGA 2000 and MEGA SOFT Reusable Patient Electrode devices.[1] The list of reported injuries is mainly comprised of severe burn injuries, being as serious as third-degree burns requiring medical intervention. As a result of these burns, patients may be forced to endure longer hospital stays, scarring, and potentially further surgeries.[2] Megadyne is currently investigating the root causes of these patient injuries.
About the MEGA 200 and MEGA SOFT Medical Devices
Megadyne Medical Products is a Utah-based medical device company that was acquired in 2017 by Ethicon Endo-Surgery, a unit of Johnson & Johnson MedTech.
As part of its listed medical devices, Megadyne manufactures the MEGA 2000 and MEGA SOFT Reusable Patient Electrodes. These medical devices have soft pads that conduct an electric current and are used to heat the patient’s skin in order to cauterize incisions and stop patient bleeding during surgery.[3] The electric current is generated by an electrosurgical generator and is delivered to the tissue with a small pen-like attachment. A return electrode pad is then used to conduct the electric current from the patient’s tissue back to the electrosurgical unit, or generator.[4]
Megadyne’s Urgent Medical Device Correction Letter
On June 1, 2023, Megadyne sent an Urgent Medical Device Correction letter to customers recommending the following actions:
Share the notification with all users involved in MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes cleaning, operating room and patient setup, and device operation during procedures.
- Confirm that personnel using the MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes follow the instructions for use as shown in the letter and available at: https://www.eifu.com
- Post the “Cleaning and Care Visual Aid and Placement and Setup Visual Aid,” both included as attachments to the letter, near the operating room to remind staff about instructions for cleaning and setup.
- Contact any facilities where products may have been shared.
- Complete the Business Reply Form attached to the letter.
-
- Fax the form to 888-214-7430 or email it to Sedgwick at [email protected] within three (3) business days.
- For additional copies of this communication or questions about returning affected products contact Sedgwick at 888-843-0254 and reference Event # 5627.
- If medical engagement with manufacturer is requested, health care providers should submit the request using the Medical Information Request website: https://www.jnjmedtech.com/mir
The letter also noted that health care providers who have used MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes during patient procedures should follow patients post-operatively in the same way with no additional action required related to the correction.[5]
Later that month, Megadyne recalled 21,200 units of the Electrode Pads which were distributed between March 11, 2021, and May 9, 2023.[6]
If you or a loved one has been impacted by one of the listed Megadyne medical devices, please contact the New York attorneys at Rheingold Giuffra Ruffo Plotkin & Hellman LLP for a free consultation today. Our experienced team has over 50 years of experience with product liability and medical malpractice cases.
[1] https://www.dailymail.co.uk/health/article-12288567/FDA-issues-recall-surgical-tools-Johnson-Johnson-KILL-patients.html
[2] https://www.fda.gov/medical-devices/medical-device-recalls/megadyne-recalls-mega-2000-and-mega-soft-reusable-patient-return-electrodes-risk-serious-burn
[3]https://www.fda.gov/medical-devices/medical-device-recalls/megadyne-recalls-mega-2000-and-mega-soft-reusable-patient-return-electrodes-risk-serious-burn
[5] https://www.fda.gov/medical-devices/medical-device-recalls/megadyne-recalls-mega-2000-and-mega-soft-reusable-patient-return-electrodes-risk-serious-burn
[6] https://www.dailymail.co.uk/health/article-12288567/FDA-issues-recall-surgical-tools-Johnson-Johnson-KILL-patients.html
David B. Rheingold, Partner
David specializes in an active trial practice primarily involving drug products, medical device liability and product liability cases. On both a state and national level, he has obtained substantial client settlements through arbitration, mediation and direct negotiations with some of the largest national and international drug and medical device makers. David has been involved in multiple high-profile legal cases including the $2.5 billion DePuy ASR and DePuy Pinnacle metal-on-metal hip implant settlement plan and the $1.4 billion Stryker Rejuvenate metal-on-metal hip implant settlement plan.
