MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
Recall
- Recall Number
- Z-2000-2023
- Event Number
- 92409
- Firm
- Megadyne Medical Products, Inc.
- FEI Number
- 1721194
- Product Code
- GEI
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- June 1, 2023
- Posted
- June 30, 2023
- Address
- 4545 Creek Rd, Blue Ash, OH, 45242-2803
Description
MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
Firm has received reports of patient burns in surgical procedures where device was used.
The firm distributed a recall notification by mail starting 06/01/2023. Customers are to provide the notice to all users of MEGADYNE MEGA SOFT and MEGA 2000 Reusable Patient Return Electrodes that participate in the cleaning, setup, and operation of affected devices. Megadyne has been made aware of 63 reports of serious patient burns since April 2018. The firm has attributed the incidence of burns to some instances that the Mega Soft Pad Instructions For Use were not being properly followed. Devices must be thoroughly rinsed after cleaning to ensure any cleaning residue is removed. Customers are asked to distribute the recall notification to all users, confirm that personnel are following the Instructions For Use, and post the provided informational attachments near the OR for staff member reference. If devices have been further distributed customers are to share the provided recall notice. Completed Business Reply Forms are to be faxed to Sedgwich at 888-214-7430 or emailed [email protected]. Any questions about the Business Reply Form can be made by phone to 888-843-0254 (Reference Event 5627). Any questions about this recall or to report a complaint can be made by phone to 1-877-384-4266, Monday thru Friday from 8:00 AM to 5:00 PM. Medical Engagement can be requested at https://www.jnjmedtech.com/mir.
Distributed US Nationwide.
21,100 units