Olympus Thunderbeat surgical instrument probe tips breaking and detaching
Olympus is recalling Thunderbeat surgical instruments due to probe tip damage, breaking, and pad detachment.
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 an FDA Class II recall for a surgical instrument with proven device malfunction (breaking probe tips, detaching pads). No injuries or illnesses reported in the source. Per the rubric, this qualifies as Score 3 (High): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling Olympus Thunderbeat surgical instruments, Model TB-0535FCS (Catalog Number R5000687). These are sterile, single-use instruments intended for use with ultrasonic and electrosurgical generators during surgical procedures.
The recalled instruments have defective probe tips that are being damaged or breaking during use. In addition, pads on the instruments are sustaining damage and may detach.
The recall affects approximately 96,253 units distributed in the United States and 399,612 units distributed internationally to over 60 countries. Healthcare facilities using or storing these instruments are potentially affected.
Healthcare providers should immediately discontinue use of the recalled instruments and contact Olympus Corporation for further instructions. Facilities should identify and remove affected instruments from service.
The recalled product
- Product
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5000687 Software Version: N/A Product Description: Thunderbeat instrument is a…
- Manufacturer
- Olympus Corporation of the Americas
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 (4)
- Model Number: TB-0535FCS
- Catalog Number/Product Code: R5000687
- UDI: 04953170409677 and 04953170383540
- Lots: All
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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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