| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00863-1 |
| Product Name/Description |
HF-Resection Electrodes
Monopolar Resectoscope
IFU version: W7089250_02
TURis/TCRis Resectoscope
IFU version: W7074650_03
Multiple Item Numbers
ARTG Numbers: 146187 and 218223 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Olympus has updated the Instructions For Use (IFU) for the HF Resection Electrodes. The IFU has been updated to include new contraindications, warnings and safety information. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Olympus is asking customers to:
1. Inspect inventory and replace any existing IFUs supplied with the device as per the list on Appendix A with the latest version provided in the customer letter;
2. Ensure all personnel are trained and/or familiarised themselves with the added contraindications, warnings and safety information as stated. Do not hesitate to contact your local Olympus Sales Specialist to organise additional training;
3. Complete the supplied reply form as per the instructions given;
4. If you have distributed or transferred any of the affected items from your facility to another, please forward this recall notice and also please notify Olympus so that we can follow up with that facility directly;
5. If you require additional hard/electronic copies of the IFU, please email RA@Olympus.com.au; and
6. If you have any queries or concerns in relation to this matter please do not hesitate to contact Olympus Customer Operations on 1300 657 699 or email RA@Olympus.com.au.
This action has been closed out on the 16/11/2018. |
| Contact Information |
1300 657 699 - Olympus Customer Operations |