Surgical GPS that guides surgeons through the body recalled because it could throw them off course – risking life-threatening injury
- The FDA announced on Monday that Brainlab had issued a Class I recall for its Spine and Trauma 3D Navigation Software
- Class I is the most serious recall, for devices that could lead to deaths and serious injuries
- No patients have died as a result of the software malfunctions
- Brainlab’s navigation system sometimes displayed the patient’s body from the wrong perspective, which could confuse surgeons during operations
A company called Brainlab has issued a recall of its spine surgery navigation technology that sometimes shows the patient’s body from the wrong perspective, the Food and Drug Administration (FDA) announced last week.
The system is intended to help surgeons navigate delicate spine procedures to correct deformities, remove tumors or screws to stabilize or repair the backbone.
But according to the recall notice, the system has displayed incorrect visual information during high-risk operations.
Sixty devices have been recalled over concerns that the errors could cause life-threatening injuries during surgeries, although no deaths have been reported.
Brainlab’s navigation system (pictured) is supposed to track and display a spine surgery patient’s body and surgical instruments to help doctors avoid dangerous areas during operations – but it sometimes it shows patients’ bodies form the wrong perspective
Any operation involving the brain or spine comes with considerable risks.
A wrong move could lead to permanent damage, paralysis or death.
Neurosurgery, which encompasses all things brain, spine and nervous system, has come a long way.
Improvements to surgical techniques have been key, but better imaging technologies have arguably been just as crucial to making these surgeries safer and more effective.
Advanced imaging software allows doctors to see details of each patient’s unique spinal and nervous system configuration clearly without doing a more invasive operation.
Brainlab’s software is meant to track the location of surgical instruments in the patient’s body so that operating physicians know exactly what to avoid and when they are nearing vulnerable, important parts of the spine.
But if the software bridging the gap between the instruments and the digital display is faulty, surgeons could find themselves unwittingly navigating their instruments toward instead of away from dangerous areas.
According to the FDA’s description, the device has sometimes displayed the surgical field from the wrong perspective.
The FDA’s recall reveals that 60 devices have been recalled, but not how many patients were suffered as a result of the malfunctions.
Brainlab plans to stop distributing the software once its replacement is ready to be pushed out.
In the meantime, the company has instructed surgeons to avoid switching between the optional views in order to minimize the chances that the surgical field perspective will get mixed up.