| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01310-1 |
| Product Name/Description |
da Vinci Standard Surgical System, da Vinci S Surgical System, da Vinci Si Surgical System, da Vinci Si-e Surgical System including all instruments and accessories used with the da Vinci surgical systems
All Serial Numbers are affected
Model Numbers: IS1200, IS2000, IS3000
ARTG Number: 97348 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
Intuitive Surgical has received 66 unique adverse event reports associated with product use scenarios that were not previously addressed in Labelling for the da Vinci S, Si or Si-e Surgical System, Instruments and Accessories.
Intuitive Surgical is initiating a correction related to labelling updates to distributed User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG)and the Natural Rubber Latex QRG as well as an Instrument Release Kit (IRK) for use with da Vinci Surgical Systems, Instruments and Accessories. The Labelling updates have been implemented to incorporate user feedback not previously addressed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is advising their customers of the changes to labelling and requesting that superseded versions are discarded and replaced with the updated product information. End users are also requested to discard the Emergency Grip Release Wrench and replace with the Instrument Release Kit which includes the release wrench and an attached instruction card. This action has been closed-out on 14/07/2016. |
| Contact Information |
02 9975 5755 - Device Technologies Australia |