Medtronic issued an urgent field safety notice regarding the potential for the Mazor X Surgical System with Positioner Type II to detach from the O.R. table unexpectedly.
The system is designed to provide an adjustable precision guidance assembly from which, after locking onto the bed and bony anatomy, an intra-operative procedure is performed.
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 holding force of the Positioner Type II latching device. Over time, this can result in the system to release from the bed frame.
As of November 2019, the company received seven complaints of this occurrence with no associate reports of patient injury. However unexpected release of the Positioner II from the O.R. table could result in the system falling onto the patient, potentially leading to blunt injury.
The issue only affects the Mazor X Surgical System with Positioner Type II.