Certain Mazor X robots could unexpectedly detach from OR table, Medtronic warns (MassDevice)
Medtronic (NYSE:MDT) said today that some of its Mazor X surgical robotic systems could detach and fall onto the OR table, potentially injuring a patient.
The problem affects Mazor X systems with posititioner Type II, the company said in an urgent field safety notice issued in the U.K. It wasn’t immediately clear if the problem that causes the system to detach affects units distributed elsewhere. No injuries have been reported, although Medtronic said it has received seven complaints of this issue occurring since Nov. 13, 2019. Possible injuries might include hemorrhage, hematoma, bleeding or fracture(s), the company said.
In the field notice, Medtronic described the problem thus:
“During pre-operative preparation, the Mazor X surgical system is raised and mounted over the OR table with the aid of the manipulator, which is the on-board automated lifting mechanism. This enables raising of the surgical system over the OR table and mounting it onto the bed frame. The positioner provides a mechanism for rigid locking of the surgical system on the OR table, after discon...
