Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: N/A

Reason: Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

Code information: All lot/serial numbers for the following products: TFL-PLS UDI: 00821925044111; TFL-PLS-JA (Japan only);

Distribution pattern: Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.