Users of Medtronic's Mazor X Surgical System may experience a hardware detachment problem in which a system piece unexpectedly releases from the OR table, according to an urgent field safety notice issued by the company in December. Mazor X is a platform indicated for precise positioning of instruments or implants during general spinal and brain surgery, in either open or minimally invasive or percutaneous procedures.
Medtronic said it had received seven complaints of the issue occurring as of Nov. 13, none of which involved patient injuries. Still, Medtronic said the issue could result in the surgical system falling onto the patient, which the company said could result in blunt injury leading to hemorrhage, hematoma, bleeding or fractures.
The company said it is working on a mitigation to permanently correct the issue, but offered instructions on how to safely set up the system in the interim to avoid negative system impact or malfunction.
Medtronic completed its approximately $1.7 billion acquisition of Mazor Robotics in December 2018. Since then, Medtronic has said growth in Mazor procedures has helped boost sales of spinal devices. On a November earnings call, Medtronic declined to specify the number of Mazor robots it has sold.
The safety notice describes that a certain positioner that's part of the system, called Positioner Type II, may detach from the OR table unexpectedly. The issue does not affect Positioner Type I.
"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 disconnecting it from the Manipulator," Medtronic described.
Medtronic said it determined that in instances when the Positioner Type II released from the OR table after being securely attached, the cause is likely slight air leakage within the pneumatic system, which over time reduces the Positioner Type II's latching device holding force. Eventually, that issue could lead to the surgical system to release from the bed frame.
The company recommends modified mounting of the system, which it says is outlined in the Mazor X user manual as well as in the safety notice.
Medtronic also offered guidance on how to distinguish between the Position Type II and the Positioner Type I. The Positioner Type II's surgeon screen is wired and its locking lever is on the back of the surgical system near the top user handle. Conversely, the Positioner Type I's surgeon screen is wireless and its locking lever is on the lower right side of the surgical system.
Medtronic included images further clarifying the Positioner Type II's locking lever and positioner plate handle in the safety notice.
In its Minimally Invasive Therapies Group, Medtronic is developing a modular robot in house, dubbed Hugo, meant for soft tissue procedures like Intuitive Surgical's da Vinci robot. The company performed a demonstrative prostatectomy in revealing the technology to analysts last September and is aiming to achieve CE marking in the second half of fiscal 2021.