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System used in brain surgery part of medical device recall

Ohioans who are receiving treatment from a medical professional will undoubtedly understand that they are placing their lives in the hands of the doctor and their staff. An understated concern when being treated for any issue is the possibility that defective medical devices are being used. Some of these devices place people at risk of serious injury and death. When there has been a medical device recall and a patient might have been injured before the recall, this could be the basis for a lawsuit to recover compensation.

A recall was initiated by the Food and Drug Administration because of problems with a laser delivery probe. The Monteris Medical NeuroBlate system was recalled due to its propensity to unexpectedly heat up and cause damage to the probe's tip, injuring the patient. The recall is Class I, which is the most serious kind of recall the FDA can order and is used when the danger of serious injury or fatality exists. The device is used to let doctors operate on a patient's brain with minimal invasiveness. The heating and damage from the tip can let carbon dioxide into the probe, which can subsequently leak into the brain of the patient.

Information regarding this issue was sent to the FDA. Included was the fate of one patient who suffered a hemorrhage and died. However, it was not determined with certainty that the patient died because of the device malfunctioning. In the recall, there are 52 devices affected in North America; forty-nine are in the United States and three are in Canada. These items were made between April 2013 and July 2017. The manufacturer sent out advisories regarding this product in the fall and winter of 2017, but the FDA did not think that the company went far enough in ensuring patient safety.

With this recall, people who might have been harmed by this defective medical device should be cognizant of their rights to seek compensation. Discussing the matter with a legal professional experienced in pursuing claims after a medical device recall can examine the circumstances and assess if there is the foundation for a case.

Source: massdevice.com, "FDA pulls select Monteris Medical NeuroBlate systems in Class I recall," Fink Densford, March 22, 2018

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