Surgical GPS that guides surgeons through the body after giving the wrong directions – leading to the death of the patient
- The FDA announced on Monday that Brainlab has issued a Class I recall for its Spine and Trauma 3D Navigation Software
- Class I is the most serious memory for devices that have resulted in deaths and serious injuries
- Some patients died as a result of the disruptions, but the FDA announcement did not specify how much
- The Brainlab navigation system sometimes showed the body in the wrong way, causing surgeons to make wrong movements during delicate operations
A company named Brainlab has issued a recall of its backbone surgery technology after errors had proved fatal for some patients, the Food and Drug Administration (FDA) announced Monday.
The system is designed to help surgeons navigate delicate spine procedures to correct malformations, remove tumors or screws to stabilize or restore the spine.
But according to the recall message, the system has displayed incorrect visual information during high-risk operations.
Sixty devices were recalled after patients in failed operations had to undergo a second corrective operation or even die on the operating table – errors that justify a Class I recall, the most serious type.
The Brainlab navigation system (photo) must track and display the body and surgical instruments of a spinal surgery to help physicians avoid dangerous areas during operations – but it sometimes gives incorrect directions, which has proved fatal to some patients
Any surgery involving the brain or spine involves significant risks.
A wrong movement can lead to permanent damage, paralysis or death.
Neurosurgery, which covers all things, brain, backbone and nervous system, has come a long way.
Improvements to surgical techniques were crucial, but better imaging technologies have demonstrably been just as crucial to making these operations safer and more effective.
With advanced imaging software, doctors can clearly see details of the unique spinal cord and nervous system configuration of the patient without performing any more invasive surgery.
Brainlab & # 39; s software is designed to track the location of surgical instruments in the patient's body so that doctors know what to avoid and when they approach vulnerable, important parts of the spine.
But if the software that bridges the gap between the instruments and the digital display is defective, surgeons may discover that they are unknowingly navigating their instruments toward, rather than away from, dangerous areas.
And that is exactly what happened with the Brainlab Spine & Trauma 3D Navigation Software.
According to the FDA description, the device has sometimes shown the surgical field postponed 90 degrees, so that instead of seeing the up-and-down orientation, a side-by-side image is shown to the surgeon, or vice versa.
The recall from the FDA reveals that 60 devices were recalled, but not how many patients were affected as a result of the disruptions.
However, it confirms that some have been injured and killed.
& # 39; The FDA is aware that some healthcare providers experienced surgical accuracy errors while operating frameless stereotaxic navigation systems & # 39 ;, says the recall.
& # 39; Some of these errors have resulted in patient death, serious or life-threatening injuries, and inaccurate, broken down, or lengthy medical procedures. & # 39;
However, based on his analysis, the FDA blames more than just the software.
It mentioned problems with both Brainlab & # 39; s hardware and software, human error, software and surgical instrument compatibility issues, poor tracking capabilities, low image quality and the simple complexity associated with working on the spine brain.
At the beginning of March, Brainlab sent a warning and instructions to repair the devices in hospitals that owned and operated them.
It has recommended restarting and re-orienting the device.
The company has promised to perform an update for corrective software in June.