| TGA Action ID |
RC-2026-RN-00843-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Model Number: GIF-XP190N
Serial Number: 2135405 |
| ARTG Number |
355250 |
| Unique Device Identifier (UDI) |
4953170305313 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Olympus determined that the affected gastrointestinal endoscope may not have been repaired in accordance with the applicable repair instructions during previous servicing. As a result, a component that controls endoscope bending may become loose, potentially resulting in loss of endoscope angulation and difficulty visualising the intended area.
Olympus has received four complaints globally relating to this problem. No associated adverse events have been reported. |
| Instructions for Customers/Users |
Customers are to:
- Identify the affected device and continue using it until repair is arranged only if the bending mechanism is inspected before each use in accordance with the Instructions for Use. Do not use the endoscope if any irregularity is observed.
- Arrange with Olympus for the affected device to be returned to an Olympus Repair Centre for inspection and repair. |
| Action Commencement Date |
21/10/2026 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |