MAUDE Adverse Event Report: COVIDIEN LLC NIM EMG - ENDOTRACHEAL TUBE - TRIVANTAGE; STIMULATOR, NERVE

Model Number	8229738
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by a health care professional that during thyroidectomy the device had no stimulation.The procedure was completed with backup product(s) with 30 minutes delay.There was no patient impact.

• Brand Name: NIM EMG - ENDOTRACHEAL TUBE - TRIVANTAGE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 12142574
• Report Number: 9612501-2021-01128
• Device Sequence Number: 4259303
• Product Code: ETN
• UDI-Device Identifier: 00763000041533
• UDI-Public: 00763000041533
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2024
• Device Model Number: 8229738
• Device Catalogue Number: 8229738
• Device Lot Number: 0220142119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1