Has a loved one suffered serious injuries or death during a head or neck surgery? This may be the result of a defective endotracheal tube. GoldenbergLaw is currently investigating EMG endotracheal tube failure lawsuits where an individual suffered a serious injury or death during a surgery where a silicon-based EMG endotracheal tube was used. Contact us today for a free consultation.
On April 27, 2022, the Food and Drug Administration (FDA) issued a Letter to Health Care Providers warning of the risk of airway obstruction when operating with silicone-based electromyogram (EMG) endotracheal tubes. The letter cited the Medtronic NIM Standard Reinforced Endotracheal Tube and the Medtronic NIM Contact Reinforced Endotracheal Tube as the only silicone-based EMG endotracheal devices marketed in the United States.
Injuries related to silicon-based EMG endotracheal tube failure include:
The FDA letter comes after the agency received multiple reports of serious injuries and deaths that occurred due to airway obstruction and/or ventilation failure during procedures where these devices were used. These adverse events involved situations where patients suffered serious injuries or died due to a lack of oxygen. When the EMG endotracheal tube is not ventilating properly, a patient cannot receive sufficient oxygen. Therefore there is a risk of oxygen deprivation, brain damage, or death if the EMG endotracheal tube is not functioning properly.
At this time, the FDA recommends health care providers:
- Be aware of the potential risk of airway obstruction and ventilation failure with silicone-based EMG endotracheal tubes.
- Follow the instructions for use in the device labeling to minimize the chance of ventilation failure and obstruction of the patient’s airway.
- Be prepared to take immediate steps to reestablish a safe airway if ventilation failure occurs. Do not reintubate with a silicone-based EMG endotracheal tube.
- Report adverse events and outcomes to the FDA. Prompt reporting can help the FDA identify and better understand the risks associated with medical devices.
If you or a loved one suffered one of the injuries listed above due the failure of a silicon-based EMG endotracheal tube, contact the Defective Medical Device attorneys at GoldenbergLaw today. We have been representing individuals harmed by defective medical devices for over 35 years. Contact us today for a free endotracheal tube injury lawsuit.