| TGA Action ID |
RC-2025-RN-00861-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Evis Exera III Duodenovideoscope
Model: TJF-Q190V
Material Number: N5995920
Serial numbers: All |
| ARTG Number |
210858 |
| Unique Device Identifier (UDI) |
N/A |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Olympus’ ongoing assessment of TJF duodenoscope reprocessing to address positive cultures and infections has identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes and is reminding users to closely follow the operation and reprocessing instructions.
The potential risk related to improper and/or incomplete reprocessing of Olympus duodenoscopes includes exposure to a contaminated device which may result in patient infection. The severity of infection would depend on overall patient health and/or risk factors (e.g. immunocompromised patients) which may range from minor to life-threatening, and possibly death in extremely rare cases.
Globally, from 2024 to present, Olympus has received 2 reports of death and 5 reports of serious injury from infection or positive culture potentially related to use of the TJF duodenoscope; these reports did not contain sufficient information for Olympus to determine if the TJF duodenoscope contributed to the transmission of an infection. |
| Instructions for Customers/Users |
Customers are required to access the Olympus education portal and complete the required training course. |
| Action Commencement Date |
13/10/2025 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |