SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX1
FDA device recall Z-0748-2024 · posted 2024-01-18 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- GEX
- Quantity affected
- 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.
- Date initiated
- 2023-12-01
- Date posted
- 2024-01-18
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories) (K183647) | Olympus Surgical Technologies America | 2019-08-09 |