Medtronic filed an urgent field safety notice with the Medicines & Healthcare products Regulatory Agency in the U.K. in December regarding its Mazor X Surgical System after receiving seven complaints from users.
The company reported the potential for its system with the Positioner Type II to detach unexpectedly from the operating room table. Mazor X is a fully adjustable precision guidance system designed to lock on to the bed and bony anatomy before the procedure is performed.
The surgical system is raised and mounted over the OR table ahead of the operation, and the positioner supports the rigid locking of the surgical system. In the notice, Medtronic reported it became aware of instances that the Mazor X Positioner Type II unexpectedly released from the OR table after secure attachment. "Investigation has determined that the occurrences are due to the potential for slight air leakage over time within the pneumatic system resulting in a gradual decrease in the Positioner Type II latching device holding force," according to the notice.
"Medtronic received complaints – none of which involved patient injuries – of the surgical system having issues maintaining a rigid connection to the operating room table," said Medtronic Restorative Therapeis Group External Communications Director David Young in a statement. "This could result in the surgical system slowly descending toward the user or patient. The company said reports are rare, but it has a mitigation to permanently correct the issue while offering instructions to all customers on how to prevent this from happening."
The company reported the problem only affects the Positioner Type II, and Medtronic said no patients have been injured as a result of the unexpected release. Medtronic is working on a way to develop a permanent fix for the issue, according to the notice.
"The mitigation we offered to our customers resolves the issue entirely," said Mr. Young. "We are now looking at long term product improvements. Our Medtronic Mazor X Surgical System representatives have been trained on this correction to the device and are present at every procedure that is performed on patients."