Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies. The software, when used with the medical device Navigation System, provides 3D images of a patient’s brain to help neurosurgeons navigate surgical tools and implants used during surgery.
The Software glitch may affect the intended use of the device. This new risk, the following does not include reported problems that included a patient death potentially linked to the case.
It was a Class 1 recall alert for MRI-guided surgery device. Class 1 recalls, the highest severity level, involve product problems that can cause death or serious injury.
Hazard: The software displays incorrect information during biopsy procedures that could result in serious or life-threatening patient harm. During the procedure, the software monitor may show that the tip of the surgical tool has not reached the target and could prevent the neurosurgeon from accurately seeing the location of the tools in the patient’s brain.
Failure Cause: The offset appears to have been caused by an interaction between the device probe and the MRI environment
Failure Effect/ Harm: The surgeon could potentially insert the tool too deeply, damaging the patient’s healthy tissue, brain or blood vessels.
Risk Control (RISK-5005):