Electrosurgical Generator ESG-410 Recalled for System Error and Reboot Malfunctions
Olympus ESG-410 Electrosurgical Generators may display a system error and reboot or enter continuous reboot loops during use. This could interrupt surgical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with a known malfunction that could disrupt surgical procedures. Although no injuries or deaths have been reported, the potential for patient harm exists if the device fails during active use, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Olympus ESG-410 Electrosurgical Generator (Model WA91307C) is being recalled due to a potential malfunction that could occur during surgical use. The device may display an error message 'E0662 System Error' and subsequently either reboot automatically or enter continuous reboot cycles.
This malfunction could interrupt active surgical procedures by temporarily disabling the device. Approximately 434 units have been distributed nationwide throughout the United States. These devices are used in open surgery, laparoscopic surgery, single-site surgery, and endoscopic procedures.
The recalled units are identified by Model Number WA91307C and Lot Code ESG-410 Legacy WA91307C. Healthcare facilities should contact Olympus Corporation of the Americas to verify if their units are affected and to obtain instructions for recall resolution.
The recalled product
- Product
- Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instr
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- system-error
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 101005
- 101006
- 101007
- 101008
- 101009
- 101010
- 101011
- 101012
- 101013
- 101014
- 101015
- 101016
- 101017
- 101018
- 101019
- 101020
- 101021
- 101022
- 101023
- 101024
Distribution
Distributed nationwide across the United States.
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