| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01031-1 |
| Product Name/Description |
da Vinci X/Xi SureForm 45
Material description: STAPLER, SUREFORM 45, SPU, CURVED-TIP, BOX O
Batch: T12221214
Material Number: 480545-04
ARTG 309263
(Device Technologies Australia Pty Ltd - Robotic surgical cutting stapler, single-use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
Intuitive has determined that a friction increase in the roll axis of the affeted staplers may result in instrument installation engagement failures.
In addition to the potential for installation engagement failure, an increase in roll axis friction may lead to:
• A decrease in the Stapler’s roll rate along the roll axis.
• Controlled distal instrument to master controller offset motion that would occur immediately upon taking control of the instrument after installation.
Please note this is an update to the previous communication TGA Ref: RC-2022-RN-01403-1 issued in November 2022. Based on further investigation, Intuitive has become aware of additional lots that are susceptible to the related issue. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Users are advised to have replacement staple devices ready to be deployed if the issue occurs and to re-read the instructional manuals. If there are further questions, users are advised to contact Device Technologies directly
This action has been closed out on 31/01/2024 |
| Contact Information |
Device Technologies - Luke Meehan - 61 436 021 157 - luke.meehan@device.com.au |