| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01248-1 |
| Product Name/Description |
Patient Side Manipulators - da Vinci S, Si, Si-e Surgical System (robotic surgical unit)
Manufactured from October 2012 to April 2013
ARTG Number: 97348 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Intuitive Surgical has become aware that friction within certain Patient Side Manipulators (ie, instrument arms) can interrupt smooth instrument motion. This interruption is felt by the surgeon as resistance in the movement of the mast. In this situation, the instrument can stall momentarily and then suddenly catch up to the master position if the surgeon pushes through the resistance. This resistance is most noticeable when moving the instrument at very slow speeds and during small movements of the masters. This system behaviours is not autonomous instrument motion. The variable function is immediately apparent to the surgeon, and they would exercise surgical judgment to continue use in only situations where the risk is low. However, they would not necessarily be anticipating an interruption of smooth instrument motion, so may not avoid all vulnerable structures.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is testing affected Patient Side Manipulators (instrument arms) and replacing or repairing instrument arms as required. Device Technologies in providing work around instructions for users to follow as an interim measure. |
| Contact Information |
1800 429 551 - Device Technologies Customer Service |