The Pipeline

FDA announces recall for da Vinci Robot—what does it mean for your robotics program?


Vik Srinivasan, Technology Insights

Amidst an ongoing FDA investigation into complaints about Intuitive Surgical’s da Vinci robot, the FDA announced a Class II recall on 30 da Vinci robots that it said may not have been tested in accordance with its standards.


More bad press for da Vinci

According to Intuitive, the affected robots have since been checked and passed re-testing without issue. Nonetheless, the episode continues a spate of negative press for the da Vinci during the first half of the year.

The continuing FDA investigation concerns the rising number of complaints associated with use of the robot. It is not yet clear whether the increase in complaints is a result of wider robot adoption. For its part, Intuitive argues that any uptick reflects a change in how the company reports incidents.


Robotics programs: Proceed with caution

With this increased scrutiny of the da Vinci, many robotics programs should move cautiously with expanding robotic adoption. Hospitals must make sure to justify their use of the robot.

The role of robotic steering committees in monitoring appropriate robot use and developing a comprehensive robotics program strategy is as crucial as ever. Clear guidelines and strong oversight can ensure the robot is being used appropriately and avoid adverse events at your institution.

Your Next Step

Need help establishing clear guidelines for making decisions about robotic surgery at your organization? Contact us for a customized assessment of your robotic surgery program.


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