| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01050-1 |
| Product Name/Description |
SOLTIVE Laser System
ARTG 349153
(Olympus Australia Pty Ltd - General/multiple surgical laser system beam guide, single-use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
Olympus conducted an internal review of the SOLTIVE Single-use Fibers and identified inconsistencies in the IFU. The IFU currently instructs the user that the SOLTIVE Single-use Laser Fiber is cleaved first and then stripped, leaving 20 mm of exposed fiber. This presents the potential for the fiber to break during use. The potential harms related to a broken fiber include burns, procedure delays, prolonged surgery, and foreign body in patient. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Provide the correct information to users in the form of an addendum to the IFU. |
| Contact Information |
oaz-fca@olympus.com |