| TGA Action ID |
RC-2026-RN-00688-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
SOLTIVE SuperPulsed laser fibre devices
SKU: R5000756, R5000758, R5000759, R5000761, R5000762, R5000764, R5000766
Models: TFL-FBX150S, TFL-FBX150BS, TFL-FBX200S, TFL-FBX200BS, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S
Manufacturing Dates: 06 Feb 2024 to 07 Jun 2026, 18 Jan 2024 to 29 Apr 2026, 27 Sep 2023 to 08 Jun 2026, 04 Oct 2023 to 03 Jun 2026, 27 Sep 2023 to 03 Jun 2026, 31 Oct 2023 to 09 Jun 2026, 06 Feb 2024 to 09 Jun 2026 |
| ARTG Number |
349153 |
| Unique Device Identifier (UDI) |
Please refer to the table on page 1 of the customer letter |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
In 2025, Olympus identified an increased number of complaints reporting thermal events associated with the use of SOLTIVE laser fibre devices. A known risk associated with these devices is that a break in the core material within the fibre can cause a dispersion of the laser energy at that location which can lead to accidental laser exposure to the patient or operating room personnel or thermal damage to or ignition of adjacent equipment or materials. In some of the reported instances in which the breakage occurred within or near the strain relief, the strain relief component itself ignited and did not immediately self-extinguish.
Through a previous notification, RC-2025-RN-00451-1, Olympus informed consignees of 175 malfunctions and two serious injuries reported globally, reminded users of the relevant safety information within the IFU, and provided supplemental guidance to help identify laser fibre devices with a broken core. |
| Instructions for Customers/Users |
Customers are to:
- Examine the carton labels of all SOLTIVE laser fibre products on hand.
- If affected stock is identified, transition to the new versions of the products as soon as possible by placing an order.
- Until the new versions of these products are received, continue using the affected versions while strictly following the safety information presented in the IFU and in the Aiming Beam Quick Reference guide.
- Once the new products are received, stop using the affected versions and set them aside for return.
- Contact Olympus at oaz-fca@olympus.com to obtain a Return Material Authorisation. |
| Action Commencement Date |
14/09/2026 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |