| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00390-1 |
| Product Name/Description |
Sterile Adapter for use with the da Vinci S, da Vinci Si, da Vinci Si-e (robotic surgical system)
Model numbers:
da Vinci S - IS2000
da Vinci Si - IS3000
da Vinci Si-e - IS3000
Serial numbers: IS2000 IFU 550516-05; IS3000 IFU 550650-05
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
The sterile adapter acts as an interface between the sterile surgical instruments and non-sterile system. Intuitive Surgical is undertaking market action to provide users of the da Vinci S, Si and Si-e Systems with additional information regarding sterile adapter engagement and instrument installation. Although rare, sterile adapter and instrument engagement issues may lead to non-intuitive motion or a sluggish response when controlling instruments. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is providing their customers with further training to ensure the correct engagement of the sterile adaptor. Additional quick reference instructions will also be provided. |
| Contact Information |
02 9975 5755 - Device Technologies |