| TGA Action ID |
RC-2026-RN-00814-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Olympus HF Cables
HF-cable monopolar
Models: A00012A, A0335.1, A0355, A0358, A0392, A0393
Lots: All
HF-cable HiQ+ bipolar
Models: A60000C, A60001C, A60003C
Lots: All
HF-cable
Model: WA00013A
Lots: All |
| ARTG Number |
194874, 370928 |
| Unique Device Identifier (UDI) |
Please refer to the table on page 1 of the customer letter |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Olympus received a complaint involving a thermal event with HF cable WA00014A that caused a minor burn. The investigation found the cable had been used beyond its IFU-defined service life and was not inspected before use, resulting in insulation wear, corrosion, and failure.
Following a March 2026 Product Alert (RC-2026-RN-00194-1) for HF cable WA00014A, Olympus identified 19 additional models (10 of which are supplied in Australia) that may experience the same failure; this notice addresses those models.
Olympus identified 60 complaints potentially related to thermal events involving the 19 additional HF cable models over the past four years, with no serious injuries. |
| Instructions for Customers/Users |
Customers are to:
• Read the Product Alert notice and ensure all personnel are completely knowledgeable and thoroughly trained on the use of the HF cables.
• As stated in the Instructions for Use, do not use the device beyond the defined service life of 12 months, and inspect all HF cables for mechanical defects prior to use. If any defects are identified, replace the cable, regardless of the first-use date or number of uses. |
| Action Commencement Date |
14/10/2026 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |