Robotic surgery systems have been a game changer in medicine, as their precise positioning and steady movements allow some procedures to be performed faster and with greater accuracy than before. On the flip side, however, malfunctions can lead to disastrous results.
That’s the scenario facing Zimmer Biomet, which is facing a Class I recall of its Rosa One Brain platform. The system combines a robotic arm and touch-screen controller to help neurosurgeons position medical tools and implants during brain surgeries.
Devices ranging from biopsy needles to endoscopes to deep brain stimulation electrodes can be attached to the end of the Rosa One arm and programmed to perform minimally invasive procedures.
According to the FDA’s recall notice, an error in the 3.1 version of the system’s software could cause those instruments to be incorrectly placed during stereotactic neurosurgeries. For example, the agency said, coordinates entered into the system to send a tool to a specific location in the brain could be misinterpreted, sending the tool to the wrong area and potentially leading to stroke, serious injury, severe disability or death.
So far, only three complaints have been submitted in relation to the issue, with no deaths or injuries linked to the software error. One of the complaints came after the system inaccurately placed an electrode on the brain during a surgical procedure.
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Zimmer Biomet first notified healthcare providers about the recall at the end of September. In an urgent medical device correction (PDF), the medtech giant noted that the software error is triggered when the device is shut down either manually or unexpectedly, then rebooted and directed to recalibrate the robotic arm.
The company said it expects the corrective update to be ready for installation by February 2022, with all updates completed by the following May.
The Rosa One Brain 3.1 application has been installed in its robotic surgery systems since December 2019 and has been used to perform approximately 3,600 brain surgeries. The recall spans a total of 119 devices distributed across the U.S., according to the FDA.
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The recall affects only Zimmer Biomet’s Rosa One systems for neurosurgery. Its Rosa One Spine application, meanwhile, is in the process of being offloaded to ZimVie, a spinout company that will comprise Zimmer Biomet’s spine and dental businesses and is expected to launch in mid-2022.
Other robotic surgery systems that will stay under the Zimmer Biomet umbrella alongside Rosa One Brain include the Rosa Knee, the Rosa Partial Knee and the newly FDA-cleared Rosa Hip applications.