Surgical instrument button malfunction may extend operative time
Olympus THUNDERBEAT surgical instruments may have a blue seal button that remains engaged after release, potentially extending surgery time. The company is recalling 271 affected units nationwide.
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 is a Class II medical device recall with no reported illnesses or injuries. The malfunction of a critical surgical instrument component creates a risk of harm by potentially extending operative time during surgery. Per the rubric, risk-of-harm products where injury has not yet been reported score at most 3 (High).
Plain-English summary
Olympus Corporation of the Americas is recalling the THUNDERBEAT surgical instrument (Model TB-0545FCS), a 5mm, 45cm front-actuated device used in open, laparoscopic, and endoscopic general surgery, gynecological, urologic, thoracic, and plastic surgery procedures.
The blue seal button on affected units may remain in the engaged position after the button is released and not immediately return to a neutral position. This malfunction can result in prolonged surgical time.
The recall affects 271 units distributed nationwide. Affected lot numbers include KR310806, KR310809, KR313734, KR319658, KR326619, KR326628, KR333661, and KR342666. Healthcare facilities using affected instruments should discontinue use and contact Olympus Corporation of the Americas for replacement or repair instructions.
The recalled product
- Product
- THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 271
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 (1)
- 2024: KR310806 KR310809 KR333661 KR342666
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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