Medtronic alerted customers of its Mazor X robotic surgery system of its potential to come loose and detach itself from an operating room table, and possibly fall upon a patient during a spine procedure.
The manufacturer has tracked the issue to the system’s pneumatic positioning hardware, which lifts, mounts and locks the device to the OR bed frame. Over time, air leakage from certain models can weaken the system’s grip, according to Medtronic.
This only affects positioners labeled as “Type II,” which feature a wired surgeon screen and a locking switch on the back of the device, near the top user handle. These differ from Type I positioners with wireless screens and a locking lever on the lower-right side.
As of mid-November 2019, Medtronic received seven complaints about the system becoming detached and no reports of patient injuries. The company’s field safety notice was published this week by the U.K. Medicines and Healthcare products Regulatory Agency.
Medtronic and its Mazor Robotics division said that it is developing a permanent fix to the pneumatic issue—but that in the interim, leaving the device’s locking switch in the “open” position would help maintain pressure without adversely affecting the system.
The MHRA also published field safety notices from GE and Philips: GE noted certain cases of point-to-point measurement errors arising in its Centricity Universal Viewer picture archiving and communication system, while Philips alerted its customers of the risk of burning out a capacitor within its Velara X-ray generator following a large number of surges in a short amount of time.