| TGA Action ID |
RC-2025-RN-01067-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Olympus Gastrointestinal Videoscope and Colonovideoscopes
GASTROINTESTINAL VIDEOSCOPE OLYMPUS
Model Number: GIF-EZ1500
Material Number: N6129031/N6129030
COLONOVIDEOSCOPE OLYMPUS
Model Numbers: CF-EZ1500DI and CF-EZ1500DL
Material Numbers: N6022431/N6022430 and N6022531/N6022530 |
| ARTG Number |
112270, 121183 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Olympus has received reports of cracking of the endoscope connector component of the Olympus Gastrointestinal Videoscope model GIF-EZ1500, and Olympus Colonovideoscope models CF-EZ1500DI and CF-EZ1500DL when the endoscopes are reprocessed using methods that have not been validated by Olympus.
Cracking of the connector could potentially allow for fluid ingress during reprocessing and therefore interfere with the video processor’s ability to relay images. |
| Instructions for Customers/Users |
Users are advised that unless they are using the reprocessing method provided in the Olympus IFU, they should confirm compatibility of their AER and detergent solution with Olympus devices from the AER or detergent supplier. If the supplier is unable to confirm compatibility, they should clean and disinfect their devices using manual methods (using validated solutions as outlined in the Instructions for Use (IFU) and below). Reprocessing methods that employ higher temperatures and more caustic/corrosive materials may lead to faster deterioration.
Olympus continues to investigate the cause of cracking using other AER methods and will provide further updates once investigations are complete (anticipated June 2026). |
| Action Commencement Date |
16/12/2025 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |