| TGA Action ID |
RC-2025-RN-00444-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
TJF-Q190V Evis Exera III Duodenovideoscope
Serial No: All
Material Code: N5992950 |
| ARTG Number |
210858 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Recent post-market surveillance data suggested a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
The current TJF reprocessing manual Section 5.9 “Presoak the endoscope” includes validated instructions to perform an extended detergent soak of the TFJ-Q190V in cases where manual cleaning cannot begin within one hour and is delayed up to 24 hours after patient procedure.
As a result of this post-market surveillance data and as a precautionary measure, Olympus no longer includes an option for delaying manual cleaning beyond one hour after patient procedure.
The reprocessing manual for the TJF-Q190V is being updated to remove the “presoak the endoscope” step and will include instructions that require manual cleaning to begin within one hour after patient procedure for the TJF duodenoscope.
Olympus’ review of complaint data identified four reports of potential delayed cleaning. None of these complaints reviewed included a report of infection or serious injury. |
| Instructions for Customers/Users |
Customers are to review the reprocessing manual along with the updates in the customer letter.
A copy of the reprocessing manual can be requested by contacting Olympus at oaz-fca@olympus.com or your Olympus Sales Specialist.
Place a copy of the customer letter with the updated instructions with the current reprocessing manual.
This action has been closed out on 26/03/2026. |
| Action Commencement Date |
8/05/2025 |
| Responsible Entity |
|
| Contact Information |
OAZ-FCA@olympus.com - Olympus |