Surgical laser system recalled for potential thermal incidents during use
Olympus SOLTIVE Pro SuperPulsed Laser System recalled due to potential thermal incidents (smoke, sparks, burning, flames) caused by fiber fracturing during clinical use. Affects 201 units worldwide.
What this means for you
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 laser system with potential for thermal incidents (smoke, sparks, burning, flames) during clinical use. No injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported warrant a High (3) severity rating.
Plain-English summary
Olympus Corporation of the Americas is recalling the SOLTIVE Pro SuperPulsed Laser System, models TFL-SLS and TFL-SLS-JA, due to a potential hazard during clinical use. The fiber component in these devices can fracture, causing or contributing to thermal incidents including smoke, sparks, burning, or unsteady flames.
These thermal incidents can occur during ureteroscopy, percutaneous nephrolithotomy (PCNL), and potential soft tissue laser applications. The recall affects 201 total units: 100 in the United States and 101 distributed to Australia, Canada, Chile, Germany, Hong Kong, Japan, and Singapore.
Healthcare facilities and practitioners using these devices should be aware of this potential safety issue. For further information about this recall and guidance, users should contact Olympus Corporation of the Americas.
The recalled product
- Product
- Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy,
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- thermal-incident
- burn-injury
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)
- TFL-SLS-JA (Japan Only)
Distribution
Distributed nationwide across the United States.
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