Surgical GPS that guides surgeons through the body reminded it could take them off course – risking life-threatening injuries
- 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 reminder for devices that can lead to deaths and serious injuries
- No patients died as a result of the software malfunctions
- The Brainlab navigation system sometimes showed the patient's body from the wrong perspective, which could confuse surgeons during operations
A company named Brainlab has issued a recall of backbone surgery technology that sometimes shows the patient's body from the wrong perspective, the Food and Drug Administration (FDA) announced last week.
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 have been recalled to ensure that the errors can cause life-threatening injuries during operations, although no deaths have been reported.
The Brainlab navigation system (photo) should track and display the body and surgical instruments of a spinal surgery to help doctors avoid dangerous areas during operations – but sometimes it shows patients' bodies from the wrong perspective
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.
Thanks to advanced image editing software, doctors can clearly see details of the unique spinal cord and nervous system configuration of the patient without performing a more radical operation.
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.
According to the FDA description, the device has sometimes represented the surgical field from the wrong perspective.
The recall from the FDA reveals that 60 devices were recalled, but not how many patients were affected as a result of the disruptions.
Brainlab plans to stop the distribution of the software as soon as the replacement is ready to be pushed out.
In the meantime, the company has instructed surgeons not to switch between the optional displays to reduce the chance of the surgical field perspective becoming confused.
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