SOLTIVE Pro Laser System Preset Parameters May Not Follow Instructions
Olympus is recalling SOLTIVE Pro SuperPulsed Laser Systems because preset treatment parameters may not be consistently applied according to product instructions. Affected healthcare facilities should contact Olympus for corrective action.
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 a Class II medical device recall with no reported injuries or illnesses. The issue involves inconsistent application of treatment parameters in a surgical laser system, which presents a potential risk of harm to patients, but the hazard is theoretical without documented adverse events.
Plain-English summary
Olympus Corporation of the Americas is recalling the SOLTIVE Pro SuperPulsed Laser System models TFL-SLS and TFL-PLS. The surgical laser systems are used for ureteroscopy, percutaneous nephrolithotomy (PCNL), and other soft tissue applications.
The recall was issued because preset treatment parameters may not be used consistently in accordance with the product's Instructions for Use. This inconsistency could affect the delivery of treatment parameters during surgical procedures.
Approximately 189 units of the affected laser systems have been distributed worldwide, including throughout the United States and in Australia, Canada, Singapore, Germany, Japan, and Hong Kong. Healthcare facilities using these systems should contact Olympus for guidance on corrective action.
The recalled product
- Product
- Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and poten
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Surgical Laser
- Hazard
- parameter-inconsistency
- improper-operation
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 (3)
- SOLTIVE Pro SuperPulsed Laser System: UDI-DI: TFL-SLS - 00821925044135
- TFL Standard Laser Unit UDI-DI: TFL-CPLU - 00821925044586
- TFL-CSLU - 00821925044593
Distribution
Distributed nationwide across the United States.
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