| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00130-1 |
| Product Name/Description |
OER-AW Endoscope Reprocessor
Impacted models of duodenoscopes: JF-20, JF-140F, TJF-M20, TJF-30, TJF-145, TJF-140F, TJF-150, TJF-160F, TJF-160VF and TJF-Q180V
ARTG Number: 185051 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
30/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
There is an update of the Operation Manual for the OER-AW Endoscope Reprocessor to instruct users of non-detachable distal cover type duodenoscopes, such as the TJF-Q180V duodenoscope, to follow the pre-cleaning and manual cleaning as stated in the duodenoscope’s reprocessing manual prior to setting them into the OER-AW.
The following warning has been added to the List of Compatible Endoscopes/Connecting Tubes and Chapter 4 “Basic Endoscope Reprocessing Operations” of the OER-AW Operation Manual - "When reprocessing the following non-detachable distal cover type duodenoscopes using OER-AW, conduct pre-cleaning and manual cleaning as detailed in each duodenoscope’s reprocessing manual". |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Olympus is requesting users to inspect their inventory and replace any existing OER-AW Operation Manuals and List of Compatible Endoscopes/Connecting Tubes with the latest version supplied.They are further advised to implement the instructions enclosed in the updated OER-AW Operation Manual. This action has been closed-out on 06/07/2017. |
| Contact Information |
1300 657 699 - Olympus Customer Operations |