MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery

FDA device recall Z-1998-2023 · posted 2023-06-30 · Open, Classified

Recall details

Recalling firm

Megadyne Medical Products, Inc.

Reason for recall

Firm has received reports of patient burns in surgical procedures where device was used.

Action taken

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 Ethicon5627@sedgwick.com. 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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GEI

Quantity affected

21,100 units

Distribution

Distributed US Nationwide.

Date initiated

2023-06-01

Date posted

2023-06-30

Location

Blue Ash, OH

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