Nim Trivantage Emg Endotracheal Tube

Reports from the field indicated that customers were experiencing problems with the Trivantage EMG tubes such as having difficulty passing the electrode check screen on the NIM mainframe immediately after intubating the patient, losing the connection between the EMG tube and the mainframe during a procedure resulting in them getting an "electrode off" or "channel not reading message" on the monitor and being unable to proceed with nerve monitoring, or getting excess noise from the tube that would sometimes also result in "lead-off" issues. 

Between 01-November-2019 and 31-October-2021, a total of 163 product events, some with more than 1 device complaint, were reported related to "lead off /connection/not reading/noisy" issues for the NIM Trivantage Endotracheal Tubes. of the 180 devices affected within these 163 complaints, a total of 70 devices led to patient impact:

-65 devices led to unanticipated extubation during the procedure to resolve the issue, severity of 1 (negligible)

-110 cases had no impact reported, with a severity of 1 (negligible)

-4 cases were aborted before the procedure could be completed, the severity of 3 (major)

-1 device led to nerve damage, which is severity of 4 (critical).

-Minor delays in the procedure were also reported for some of these events, none reported impact or injury due to the delay.

product testing has determined that the root cause of the "lead-off" issue is the inconsistencies of the Loctite and Dymax Adhesives that are applied to the tube. The Loctite is applied to hold the Electrodes in the cCampshell on the device to secure the wire harness and connect to the conductive silver ink, and the Dymax is applied along the length of the silver electrode ink traces to provide adherence and insulation. This issue impacts specific production lots manufactured between 28-August-2019 and 25-October-2021. Corrective actions have been implemented to address the underlying issue and new products will not be impacted by this issue.

Recall start date: December 23rd , 2021.