Recall Z-1921-2025 · GEX Powered Laser Surgical Instrument
Olympus Corporation of the Americas
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
| Date | Jun 6, 2025 (initiated May 6, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On May 6, 2025 URGENT: MEDICAL DECIVE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this letter, including Appendix 1 detailing the relevant Instructions for Use sections. 2. Ensure all surgeons and personnel are completely knowledgeable and thoroughly trained on the content of this letter, the instructions provided for detecting fiber damage, Appendix 1, and the SOLTIVE Laser System and Fibers |
| Quantity | 1549 units (1025 US, 524 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242191 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Acc Olympus Surgical Technologies America, Aug 23, 2024 |