| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00531-1 |
| Product Name/Description |
Olympus HF-Resection Electrode
Multiple Model Numbers and Product Descriptions
ARTG 289009
(Olympus Australia Pty Ltd - Endoscopic electrosurgical electrode, bipolar, single-use)
ARTG 218223
(Olympus Australia Pty Ltd - Endotherapy electrosurgical diathermy system electrode, single-use)
ARTG 146187
(Olympus Australia Pty Ltd - Electrosurgical system, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/06/2023 |
| Responsible Entity |
|
| Reason/Issue |
There are complaints where the loop wire at the distal end of the HF resection electrode broke after contact with metal objects, such as other endoscopic equipment, implants, or stents. As a result, fragments can fall inside the patient and must be retrieved.
An additional caution to the Instructions for Use (IFU) of the HF resection electrodes will be added.
For some electrode models a second additional caution has been added, which was already included in the IFU of the other models. The second caution refers to the risk of sparkover when getting in contact with metal parts. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
1. Customers are to download copies of the IFU addenda attached to the customer letter (provided by Sponsor to affected customers).
2. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of the updated addendas. In particular, observe the instructions of the additional cautions.
This action has been closed out on 31/10/2023 |
| Contact Information |
1300 132 992 - Olympus Customer Operations |