| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01067-1 |
| Product Name/Description |
da Vinci S Surgical System, IS2000; da Vinci Si Surgical System IS3000 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
The Patient Cart is a robotic platform used for da Vinci Surgery. During normal use the cart can be exposed to small amounts of fluids from the environment (during cleaning for example) without impairing function. Improper cleaning techniques involving application of excessive amounts of fluid in a splashing or spraying manner can result in penetration of fluids inside the covers. During surgical procedures there is also a small risk that fluid can be transferred inside the Patient Cart, for example, biological or i.v. fluids. The system User Manual at the time instructed the user to contact Intuitive Surgical in the cases where components came into contact with liquids. However, there was no specific warning about the consequences of exposure to liquids.
This recall action was carried out prior to approval of the recall strategy by the Therapeutic Goods Administration. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies has installed a fluid ingress protection kit on all IS2000 and IS3000 systems. |
| Contact Information |
02 9972 8371 - Device Technologies |