Medtronic—NIM Standard Reinforced EMG Endotracheal Tubes: Manufacturer Advises Users of Safety Concerns Related to Excessive Bending
July 6, 2016 | Risk Management News
ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at firstname.lastname@example.org.
In a June 28, 2016, Urgent Product Safety Advisory letter submitted by ECRI Institute member hospitals, Medtronic states that it has received reports of the above tubes, where the ends of electrode wires at the distal end of the tube have extruded through the wall of the tube, entering the cuff and/or puncturing the cuff and becoming exposed. Medtronic also states that 4 of these reports involved serious injuries. Three incidents in which an extruded/protruding electrode wire penetrated the tracheal wall or a vocal cord were reported in China, and one incident involving cuff deflation that necessitated re-intubation of the patient was reported in the U.S....