| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00841-1 |
| Product Name/Description |
10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescope
10mm 0Deg Infrared Telescope
Model Number: WAIR100A
10mm 30Deg Infrared Telescope
Model Number: WAIR130A
All Lot/Serial Numbers
ARTG Number: 146202
(Olympus Australia Pty Ltd - Endoscope element, telescope) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/07/2018 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer Olympus Winter & Ibe has updated Section 7.9.1 Gas Sterilisation in the Instructions for Use for the WAIR100A and WAIR130A to include the following warning:
“WARNING
Risk of Injury to the patient and user
- Toxic gasses can enter internal volumes of the product during gas sterilisation. The gasses can remain in the product and can leak out during use.
- To remove toxic gasses, aerate the product sufficiently after sterilisation.” |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Olympus is requesting users:
1. Inspect their inventory for any WAIR100A or WAIR130A Infrared Telescopes within their control;
2. Remove any existing Instructions for Use (IFU) and implement use of the updated IFU;
3. Ensure all reprocessing personnel are informed of the additional warning. Please do not hesitate to contact your local Olympus Sales Specialist to organise additional training;
4. Complete the reply form supplied with the customer letter and email to RA@Olympus.com.au or fax to 03 9562 6438; and
5. If you have distributed or transferred any of the affected products from your facility to another, forward the recall letter to them and notify Olympus so that they can follow up with that facility directly.
This action has been closed out on the 21/11/2018. |
| Contact Information |
1300 657 699 - Olympus Customer Operations |