| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00231-1 |
| Product Name/Description |
da Vinci X Patient Side Cart Arm Controller Joint Circuit Boards
Model Number: IINS-IN4200
Serial Number: SL0015
ARTG Number: 97348
(Device Technologies Australia - Robot, surgical, operation unit) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Intuitive Surgical has become aware that circuit boards in specific da Vinci X Surgical System arms are susceptible to early failures that may result in system faults. The affected arms include Arm Controller Joint Circuit Boards manufactured with components from a specific manufacturing lot that, due to manufacturing variations, may fail prematurely.
As indicated in the User Manual, if an arm-specific fault occurs on a system during a procedure and the fault cannot be recovered, the affected arm can be disabled and the procedure may be continued with three arms.
If a fault that is not arm-specific occurs, restarting the system may clear the fault. However, the fault may recur. The user may then decide to abort the da Vinci procedure or convert to an alternate surgical method.
There have been no patient injuries as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Device Technologies will be replacing the affected Arm Controller Joint Circuit Boards as a permanent correction.
This action has been closed out on the 12/11/2018. |
| Contact Information |
07 3623 1400 - Device Technologies |