Device product
MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
Z-1998-2023
Product summary
- Event
- Event 92409
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 21,100 units
- Official record key
device-enforcement:Z-1998-2023
Official wording
Reason: Firm has received reports of patient burns in surgical procedures where device was used.
Code information: Model No. 0845; UDI-DI: 10614559103906; All Units.
Distribution pattern: Distributed US Nationwide.
Derived failure modes
-
Unknown
Firm has received reports of patient burns in surgical procedures where device was used.