Zimmer Biomet has recalled its Rosa One 3.1 brain application because of a software error that could lead to the misplacement of instruments during neurosurgical procedures.
Rosa One comprises a mounted touch screen and a robotic arm designed to assist neurosurgeons position medical instruments or implants during surgery. Examples of tools or instruments that can be attached to the robotic arm include endoscopes, biopsy needles, stimulation or recording electrodes.
The software issue could, for example, affect techniques that direct surgical tools using coordinates provided by medical imaging to reach a specific part of the brain. If this occurs, it could cause adverse events such as stroke, severe injury, disability or death, according to the FDA, which identified this as a Class I recall, the most serious type of recall.
As of Oct. 29, three complaints have been filed about the issue. One of the complaints was submitted after the robot inaccurately placed an electrode on the brain during a procedure.
No patient injuries or deaths have been reported, the company said.
In a statement provided to Becker's Spine Review, Zimmer Biomet said it has "notified users of the Rosa One 3.1 brain application of a software upgrade to address the anomaly." While the software upgrade is being implemented, the company said it "will work with surgeon users to ensure that there is no disruption to their ability to safely perform procedures on their patients."
On Sept. 22, Zimmer Biomet issued an "urgent medical device correction" that described when the issue may occur and provided steps for hospital staff and surgeons to follow to avoid it.
According to the medtech company, the software issue may occur when the system shuts down either manually or unexpectedly after registration of the patient. After reboot, if the trajectory is interrupted by the deactivating pedal, the device gives the user an option to "return to home", "clear the robotic arm," or "continue." If the user chooses to "clear the robotic arm," the device asks the user to perform an empty device calibration. If the user performs this step and presses start, the issue will occur, which results in the device driving to an incorrect trajectory.
Corrective updates to the system are expected to be ready for installation by February 2022, with all updates completed by May 2022, Zimmer Biomet said.
Since December 2019, the Rosa One Brain 3.1 application has been installed in the company's robots and has been used to perform about 3,600 brain surgeries. The FDA said that 119 devices have been recalled in the U.S.