| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00291-1 |
| Product Name/Description |
Intuitive Surgical Inc. da Vinci Xi Surgical System Patient Cart Arms
Inner Arm
Model Numbers: 380662-20, 380662-21
Outer Arm
Model Numbers: 380663-20, 380663-21
Universal Surgical Manipulator
Model Numbers: 380647-20, 380647-22
ARTG Number: 97348 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
The system reports a “23008” system software fault that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints. The system may fault during start up tests or during use. The system fault is an arm-specific recoverable fault, which leaves the system in a safe state. A fault message will be displayed and the affected arm LED colour will change to yellow. The source of the fault is the premature failure of a position sensor located within the faulting joint.
There have been no reported injuries as a result of this issue. In a scenario in which the decision is made to convert a procedure to an alternate surgical method due to the error, the patient may be at higher risk of surgical complications because of the historically higher rate of complications in open surgery. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Device Technologies representative will contact affected customers to schedule a remote assessment to determine the health of the systems and further schedule an appointment to replace the affected arm. In the interim, users are advised that if the error persists (i.e. the fault cannot be recovered), the affected arm should be disabled and the user should decide to continue the procedure with 3 arms, abort the procedure, or convert to an alternate surgical technique. This action has been closed-out on 9/08/2016. |
| Contact Information |
1300 338 423 - Device Technologies Australia |