Recall Z-0135-2025 ยท GEX Powered Laser Surgical Instrument
Olympus Corporation of the Americas
Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
| Date | Oct 18, 2024 (initiated Aug 13, 2024) |
| Status | Open, Classified |
| Reason | The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy. |
| Root cause | Under Investigation by firm |
| Action | Olympus issued Urgent Medical Device Correction Letter on 9/12/24 to Operating Room Director, Risk Management. Letter states reason foe recall, health risk and action to take: 1. Carefully read the content of this notification. 2. Please check all areas of your facility to determine if you have the devices specified above. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and the Soltive Laser System Instructions for Use. 4. If you have further distributed this product, identify your customers, and forward them this notification. 5 |
| Quantity | 159 units |
| 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
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories Gyrus Acmi, Inc., Jan 27, 2023 |