News | Procedure Navigation Systems | July 06, 2017

Advisory based on recent reports of navigational accuracy errors during surgical procedures

July 6, 2017 — The U.S. Food and Drug Administration (FDA) recently issued a safety communication alerting healthcare providers about recent reports of navigational accuracy errors during surgical procedures when using frameless stereotaxic navigation systems. The administration said some of these errors have led to patient deaths, serious or life-threatening injuries, and inaccurate, aborted or prolonged medical procedures.

Based on their analysis, the FDA believes that there are many factors that contribute to these errors, and no particular system carries greater risk than others. The administration is working with device manufacturers to ensure accurate labeling that includes clear user instructions on how to minimize the occurrence of these issues.

Stereotaxic navigation systems include a computer system that utilizes patient imaging (e.g., computed tomography, magnetic resonance imaging) to guide surgeons with the placement of specialized surgical instruments and implants before and during the procedure. Stereotaxic systems are generally considered framed or frameless.

While this communication is focused on frameless stereotaxic navigation systems since these systems are more commonly used, many of the recommendations provided are applicable to framed and frameless stereotaxic navigation systems.

The FDA recommends that healthcare providers consider the following information and actions to reduce the potential of serious adverse events:

  • Be aware that based on current information, the FDA believes the overall benefits of these devices continue to outweigh the risks in appropriately selected patients when used by properly trained surgeons, and they have not determined that any particular system carries greater risk than others;
  • Assess navigational accuracy repeatedly throughout a procedure when using a surgical navigation system.
    • Reconfirm accuracy by positioning the navigated instrument tip on an identifiable anatomical landmark and comparing the actual tip location to that displayed by the system; and
    • If the stereotaxic navigation system does not appear to be accurate despite troubleshooting (e.g., resetting the system), do not rely on the navigation system.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program

For more information: www.fda.gov/medwatch/report

Related Content

News | Orthopedic Imaging

October 24, 2019 — EOS imaging announced the first patient cases performed with its hipEOS 3.0 surgical planning ...

Time October 24, 2019
arrow
News | Orthopedic Imaging

International medical imaging information technology (IT) and cybersecurity company Sectra is extending its pre-operative orthopedic planning solution for trauma cases with 3-D templates from one of the largest orthopedic companies, DePuy Synthes. Pre-operative planning for trauma cases using templating in combination with 3-D computed tomography (CT) images enables improved surgical outcomes.

Time October 17, 2019
arrow
News | Mobile C-Arms

Digital medical technology company Brainlab unveiled Loop-X, which it calls the first mobile intraoperative imaging robot, at the 2019 North American Spine Society annual meeting (NASS 2019), Sept. 25-28 in Chicago.

Time September 26, 2019
arrow
News | Virtual and Augmented Reality

A UCLA-led study has found that using three-dimensional virtual reality (VR) models to prepare for kidney tumor surgeries resulted in substantial improvements, including shorter operating times, less blood loss during surgery and a shorter stay in the hospital afterward.

Time September 25, 2019
arrow
Technology | Virtual and Augmented Reality

Medivis announced that its augmented reality (AR) technology platform for surgical applications, SurgicalAR, has received 510(k) clearance for clinical use in the operating room by the U.S. Food and Drug Administration (FDA). The New York City-based medical technology company will commence the immediate commercialization of the platform in the United States.

Time June 10, 2019
arrow
News | Advanced Visualization

Pickup Family Neurosciences Institute at Hoag in Newport Beach, Calif., announced the addition of the 7D Surgical System for spinal procedures. This system uses the same technology found in self-driving cars to provide a new level of surgical navigation for radiation-free placement of spinal implants.

Time April 26, 2019
arrow
Technology | Virtual and Augmented Reality

Medical imaging and visualization company Medivis officially unveiled SurgicalAR, its augmented reality (AR) technology platform for surgical applications, at the 2019 Healthcare Information and Management Systems Society (HIMSS) annual meeting, Feb. 11-15 in Orlando, Fla.

Time February 14, 2019
arrow
News | Procedure Navigation Systems

Medtronic is recalling the Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System due to reports of incorrect information displaying during biopsy procedures. The company said this could result in serious or life-threatening patient harm.

Time February 05, 2019
arrow
News | Procedure Navigation Systems

Stryker's Advanced Guidance Technologies business (formerly known as Stryker's Navigation business) has entered into strategic partnerships with Synaptive Medical and Ziehm Imaging, strengthening Stryker's position in the surgical guidance market.

Time November 20, 2018
arrow
Technology | Orthopedic Imaging

EOS imaging announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its hipEOS 3.0 surgical planning software.

Time June 13, 2018
arrow
Subscribe Now