The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning ROSA Brain 3.0.0 Robotic Surgical Assistant [Serial number: BR15002], manufactured by Medtech SA.
According to the manufacturer, investigation revealed that a computer file parameter that is linked to the robot arm calibration has been modified by the robot arm supplier without notification to the manufacturer. As a result, once the robot arm is on a trajectory, if the system reboots or shuts down (voluntarily or due to an error) without the robot arm returning to a Parking position, the device's applicative accuracy may decrease to a level below the applicable specification. In the event that the inaccurate tool positioning of the instruments by the ROSA devices is not detected by the user, it could ultimately lead to ineffective treatment, serious injury or death of the patient. To date, no complaint reports, which could be linked to the above issue in normal conditions of use, have been recorded.
For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00404-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 March 2017