An essential imaging system used by doctors during brain and spinal surgeries has a serious malfunction putting patients at risk for severe and possibly fatal injuries.
An urgent field safety notice was issued by Medtronic for its O-arm™ O2 Imaging System in late 2019. The imaging system’ internal motor drive belt loosens after extended use which results in the x-ray, or image, being rotated as it relates to the actual physical position of the patient during a surgery. The imaging is a key part of a surgical procedure because to allows the surgeon to navigate to the exact treatment area whether it is a damaged spinal disc or a brain tumor. If the images are even slightly off, there is the possibility of major injury to the patient.
What is the Medtronic O-arm™ Imaging System
The O-arm O2 Imaging System is a mobile x-ray system used to take 2D fluoroscopic and 3D imaging during spine, orthopaedic, brain, and trauma-related surgeries.
The imaging system provides real-time 2D and 3D intraoperative images of the patient during surgery allowing surgeons to plan and perform procedures with improved accuracy.
For example, during minimally invasive brain or spine surgery, a surgeon can use the O2 system to map out the plan for the procedure including which incisions they will make, how they will access and remove affected lesions, and where they will place of medical devices such as spinal pedicle screws.
The system also allows the surgeon to identify key anatomical landmarks which lessens the risk of injury to the nerves, blood vessels or other vital structures.
Dangerous Issue and Possible Injuries
According to the Medtronic November 2019 safety notice, the system’s internal motor drive belt loosens after an extended number of uses. When that happens, the image, or map of the patient’s anatomy, may be rotated or shifted so that it no longer matches the physical positioning of the patient.
Even the most minor of shifts of the imaging can potentially result in serious and life-threatening nerve, spine or brain injury to the patient. Because of this defect, when a surgeon begins to treat a compressed spinal disc or remove a brain tumor and uses the shifted or rotated image to orient themselves and navigate to the affected area, they could be unnecessarily cutting through a nerve or blood vessel and causing a major injury.
How Meyers & Flowers can help
Meyers & Flowers is nationally known for our work seeking justice for those injured by defective medical devices such as the Medtronic O-arm™ Imaging System and are ready to provide you with information about your legal recourse.
If you or a loved one has suffered serious injury, or worse, we can help. We are relentless in fighting for the injured. Call us today for more information about filing a claim for damages in a Medtronic O-arm™ Imaging System injury case.