Recall Z-1997-2023 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Megadyne Medical Products, Inc.
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery
| Date | Jun 30, 2023 (initiated Jun 1, 2023) |
| Status | Open, Classified |
| Reason | Firm has received reports of patient burns in surgical procedures where device was used. |
| Root cause | Under Investigation by firm |
| Action | 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. Customer |
| Quantity | 21,100 units |
| Distribution | Distributed US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080741 | MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE Megadyne Medical Products, Inc., Dec 16, 2008 |