| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00862-1 |
| Product Name/Description |
Intuitive Surgical – da Vinci X/Xi Vessel Sealer Extender and SynchroSeal
Product numbers: 480422, 480440
ARTG 319355
(Device Technologies Australia Pty Ltd - Robotic electrosurgical instrument, bipolar, single-use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
In 2022 Device Technologies issued a Safety Alert (RC-2022-RN-00491-1) as they became aware that placing excessive tissue in the instrument jaws of the Vessel Sealer Extend or SynchroSeal instruments prior to sealing and transection can result in an insufficient seal resulting in either immediate or delayed bleeding.
The Safety Alert noted that Intuitive Surgical were working on updating user documentation with appropriate revisions to existing warning/cautions. The updates made to the applicable da Vinci User manuals have been available in Australia since August 2023. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to:
1. Read and understand the contents of the letter.
2. Access the updated user manuals via the links and save a copy these in their files. |
| Contact Information |
02 9972 8328 - Rebecca Sutton |