| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00701-1 |
| Product Name/Description |
da Vinci Xi 5mm-8mm Universal Cannula Seal and da Vinci Xi 12mm & Stapler Universal Cannula Seal
Universal Seals, 5mm-8mm
Part Number: INS-740361
Stapler Universal Cannula Seal, 12mm & Stapler
Part Number: INS-470380
ARTG Number: 181744 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Device Technologies Australia (DTA) in conjunction with the manufacturer, is issuing this warning notice in relation to the use of da Vinci Xi 5mm-8mm Universal Cannula Seal and da Vinci Xi 12mm & Stapler Universal Cannula Seal in all surgical procedures.
During internal inspections, Intuitive Surgical has identified particulate in the insufflation stopcocks on the da Vinci Xi 5mm-8mm Universal Cannula Seal. The particulate generated from the seal material has the potential to be introduced into the cannula lumen when insufflation is connected. There have been no injuries reported related to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised to not use the da Vinci Xi 5mm-8mm Universal Cannula Seal or the da Vinci Xi 12mm & Stapler Universal Cannula Seal for insufflation, or open the stopcock during all types of surgical procedures until this issue is resolved. It is recommended to use an alternative device such as an angio-catheter, Veress needle or laparoscopic trocar for initial access and to maintain insufflation throughout all procedures as an alternative to insufflation through the da Vinci Xi 5mm-8mm Universal Cannula Seal (INS-470361) or the da Vinci Xi 12mm & Stapler Universal Cannula Seal (INS-470380). This action has been closed-out on 20/02/2017. |
| Contact Information |
07 3623 1400 - Product Manager, Device Technologies |