Olympus Thunderbeat Surgical Instruments Recalled for Damaged Probe Tips
Olympus Corporation is recalling Olympus Thunderbeat surgical hand instruments (Model TB-0545FCS) due to probe tips that are being damaged or breaking, which may affect instrument function during medical procedures.
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 a real risk of harm from broken or damaged probe tips. No illnesses or injuries have been reported, which aligns with the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument, Model TB-0545FCS (Catalog Number N5423510). A total of 112 units have been recalled. These instruments are intended for use with the Ultrasonic Generator (USG-400), Electrosurgical Generator (WSG-400), and Thunderbeat Transducer (TD-TB400).
The probe tips of these hand instruments are being damaged or breaking, including pad damage and detachment. These defects may affect instrument performance and safety during surgical procedures.
The recalled instruments were distributed internationally to healthcare facilities outside the United States. Healthcare facilities and medical professionals with these instruments should contact Olympus Corporation of the Americas for instructions regarding replacement, correction, or return of the affected devices.
The recalled product
- Product
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423510 Software Version: N/A Product Description: Thunderbeat instrument is a…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 112
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 (5)
- Model: TB-0545FCS
- Catalog Number/Product Code: N5423510
- UDI: 04953170383533
- 04953170383530
- 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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