| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01414-1 |
| Product Name/Description |
Intuitive Surgical Endoscope Instrument Control System - da Vinci Xi Surgical System with P5 software
Model Number: INS-IS4000
ARTG Number: 97348 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that during an internal test, the left hand control (master) on the surgeon console moved unexpectedly upon the first entry into following mode. The system is in following mode when the surgeon is controlling the instruments at the surgeon console. This behaviour was determined to be associated with a software anomaly in the da Vinci Xi Surgical System P5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances. Certain interactions with the patient cart (during patient cart docking, or during Multi-port procedures, repositioning the instrument arm) can trigger this behaviour upon entering following mode. The surgeon may receive a recoverable error, experience movement of the master controller and/or movement of the associated cannula/instrument in any direction including potential lateral movement. There is a remote probability of patient harm associated with this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A software update will be released by Intuitive Surgical to address the anomaly which is expected in quarter 1 2017. In the interim, to prevent this event from occurring, users are advised to follow the instructions below during every da Vinci Xi procedure:
1.During Single-Site surgery, after installing each instrument on the sterile adapter, ensure instrument clutch is not activated and press the port clutch* button for that arm. This is only necessary at the beginning of the procedure, directly after the docking.
2.During Multi-Port surgery:
- Immediately after docking to a cannula, press the corresponding port clutch button for that arm, and
- If adjusting patient clearance and mid-procedure, ensure instrument clutch is not activated and press the corresponding port clutch button for that arm after the adjustment. This action has been closed-out on 11/05/2017. |
| Contact Information |
07 3623 1400 - Device Technologies |