Olympus Thunderbeat Surgical Device Recall Due to Adverse Events
Olympus is recalling 9,542 Thunderbeat surgical devices worldwide due to continued reports of adverse events. The recall affects all lots of the TB-0545FCS model.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall with continued reports of adverse events, which meets the rubric criterion for Severe (FDA Class II with hospitalization reports or significant injury reports).
Plain-English summary
Olympus Corporation of the Americas is initiating a removal of the Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S surgical device due to continued reports of adverse events. The product is a medical device used in surgical procedures.
The recall affects 9,542 units distributed worldwide, including US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan. The recalled devices include all lots of Model No. TB-0545FCS with UDIs 04953170383533, 04953170383526, 04953170409684, and 04953170383519.
Healthcare facilities and users who have the recalled Thunderbeat devices should follow their institution's procedures for recalled medical devices. Facilities should contact Olympus Corporation of the Americas regarding the removal and any necessary replacement or corrective actions.
The recall was classified as FDA Class II, indicating that use of or exposure to the device may cause temporary or medically reversible adverse health consequences, or where the probability of serious temporary or medically reversible adverse health consequences is high but the consequences could not be deemed permanent.
The recalled product
- Product
- Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 9,542
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 (6)
- Model No. TB-0545FCS
- UDI: 04953170383533
- 04953170383526
- 04953170409684
- 04953170383519
- All Lots.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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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