Patients here in Texas put their trust in their health care providers, and that trust is usually honored by a high standard of care. Unfortunately, there are times when a doctor, nurse or other medical professional may make a mistake that seriously impacts a patient’s health, possibly even resulting in death. It is imperative not only that patients can rely on their care providers, but that those care providers are able to rely on the safety and efficacy of any tools they may use in their practice. A defective medical device may lead to a medical malpractice suit, as patients and their families try to deal with the devastating consequences of a medical error. Recently, the Food and Drug Administration issued a recall for a brain scanner over concerns that it could cause surgeons to make a grave mistake during brain surgery.
The device at the center of this recall is a piece of software that works during deep brain stimulation procedures. The software is meant to give surgeons brain images that assist them in placement of implants. The company that created the software has specifically recalled a portion of the software that offers an auto-registration feature. If a patient makes small movements during the portion of the procedure that utilizes auto-registration, it could result in misplacement of leads used to map patients’ brains.
Representatives for the FDA are concerned that these errors could have devastating and negative impacts for patients. The recall issued has been designated as class 1, meaning the device could cause serious injury or fatality. Several reports of injury and malfunction have already been reported in connection with this software.
Though many people don’t realize it, surgical errors are a significant cause of death in this country. Patients deserve the best care possible from medical professionals, and a defective medical device undermines that goal. Those here in Texas who have been harmed by the negligence of anyone in the medical community may want to file a medical malpractice claim. An experienced attorney can assist those who have questions.