Electrosurgical Generators Olympus ESG-410 May Fail to Power On
Olympus is recalling 86 ESG-410 Electrosurgical Generators because they may fail to power on during use, potentially delaying treatment or prolonging surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 FDA Class II recall involves a confirmed device malfunction (failure to power on) that could disrupt necessary surgical treatment. Although no illnesses or injuries have been reported, the operational failure presents a risk of harm in surgical settings.
Plain-English summary
Olympus Corporation of the Americas is recalling 86 ESG-410 Electrosurgical Generators distributed nationwide. The ESG-410 is used in open, laparoscopic, and endoscopic surgeries for cutting and coagulating tissue.
The recalled generators may fail to power on when used. This malfunction can result in delays in initiating treatment or prolonged surgical procedures.
The affected units are identified by specific serial numbers provided by the FDA. Healthcare facilities should check whether any of their generators match the recalled serial numbers and stop using any affected units.
Facilities with recalled devices should contact Olympus Corporation of the Americas for instructions on replacement or repair. Consult the FDA recall notice for a complete list of serial numbers and additional details.
The recalled product
- Product
- ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 86
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)
- UDI-DI: 04042761086349 Serial Numbers: 102410
- 102409
- 102408
- 102419
- 102418
- 102417
- 102416
- 102420
- 102412
- 102407
- 102394
- 102393
- 102401
- 102400
- 102405
- 102404
- 102403
- 102428
- 102424
- 102422
Distribution
Distributed nationwide across the United States.
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