| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00892-1 |
| Product Name/Description |
Intuitive Surgical Battery Box of the da Vinci STM and da Vinci SiTM Surgical Systems
Product number for the battery box: 371268-02
Manufactured between 22 November 2005 and 09 July 2012
ARTG Number: 97348 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Patient Side Cart battery boxes returned to Intuitive Surgical from the field have revealed, in some rare charging conditions, the battery has been found to heat sufficiently to cause the battery case to bulge. A battery case that has bulged has the potential to release some of its internal gases to the surrounding air. The da Vinci STM and da Vinci SiTM Surgical Systems are designed to detect overheating batteries and issue a system warning, Error Code 808 is displayed on the Surgeon Console and Patient Side Cart monitors. When this event is detected, the system disables the charging of the battery until it cools down. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised that they may continue to use their da Vinci S, Si and Si-e Patient Side Carts. However, if users receive an Error Code 808, or experience a sulfur odour while using da Vinci STM or da Vinci SiTM Surgical System, they are advised to contact their Device Technologies representative, following standard troubleshooting process. For product already in use, Device Technologies is utilising standard repair and preventative maintenance programs to monitor battery performance and perform battery replacement as needed. This action has been closed-out on 06/06/2016. |
| Contact Information |
1300 338 423 - Device Technologies |