| TGA Action ID |
RC-2026-RN-00342-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Da Vinci 5 (dV5) System equipped with the Near Infrared (NIR) Handheld Camera
ASSY, DV5 TOWER, IS5000
Part Number: 380746 |
| ARTG Number |
97348 |
| Unique Device Identifier (UDI) |
00886874119662 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A condition has been identified where NIR modes may unintentionally remain active when visible white light illumination is turned off during normal workflow transitions, notably when switching from the handheld camera to the robotic endoscope. Due to the Camera Head button functionality, users may believe all illumination has been deactivated when the system is still operating in near-infrared (NIR) mode.
This may result in thermal injury if the distal end of the light guide (detached) or assembled laparoscope contacts the patient, user, or sterile drapes while NIR mode is active. |
| Instructions for Customers/Users |
Customers are to:
- Arrange for a Device Technologies representative to attend their facility to implement the configuration update.
- Identify affected product by inspecting the label on the NIR handheld camera control unit (CCU) and, prior to use, ensure the Light Source is in Standby Mode in accordance with the customer letter instructions. |
| Action Commencement Date |
6/05/2026 |
| Responsible Entity |
|
| Contact Information |
1300 338 423 - Device Technologies Australia |