Recall Z-0748-2024 · GEX Powered Laser Surgical Instrument
Olympus Corporation of the Americas
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
| Date | Jan 18, 2024 (initiated Dec 1, 2023) |
| Status | Open, Classified |
| Reason | Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient. |
| Root cause | Labeling Change Control |
| Action | On December 1, 2023, the firm issued URGENT MEDICAL DEVICE CORRECTION letters to affected customers. Customers were provided with copies of the labeling addendum to add to remaining inventory. Customers may continue to use the product, but this should be done in accordance with the labeling addendum. If you require additional information, please contact Olympus at (647) 999-3203 or at Cynthia.Ow@Olympus.com. |
| Quantity | 82,200 total units (5 per box) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Europe, Hong Kong, Australia, Japan, Singapore, and Latin America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183647 | SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELaser Fibers, and Acce Olympus Surgical Technologies America, Aug 9, 2019 |