MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®; STIMULATOR, NERVE

Model Number	8229737
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2018
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
A health care provider (hcp) reported via a manufacturer representative that the cuff of the device could not be deflated completely and there was 10cc left.The patient was alive and there was no any patient symptoms.The cuff was not deflating and it was discovered after the thyroidectomy surgery.A back-up device was not needed.On extubation, the distal balloon still contain air (10cc) after emptying.The extubation of the system was more difficult.There was a potential risk of injury or obstruction during extubation, but there was no patient consequence in this case.
Additional Manufacturer Narrative
It was reported that the initial event date ((b)(6) 2018) was incorrect.An email was received and reported that the correct event date was (b)(6) 2018.Analysis found that although the customer indicated the cuff was not deflating, to determine there was 10cc left in the cuff it would have had to been deflated.Visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event.A syringe was used to deflate the cuff completely, 8cc of air was left in the cuff.A syringe was attached, the cuff was inflated with 15cc of air, disconnected, reconnected, and 15cc was removed.This process was repeated 10 times with no issue.(b)(4).

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8041138
• Report Number: 1045254-2018-00566
• Device Sequence Number: 1525922
• Product Code: ETN
• UDI-Device Identifier: 00643169782648
• UDI-Public: 00643169782648
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 06/05/2022
• Device Model Number: 8229737
• Device Catalogue Number: 8229737
• Device Lot Number: 0215599961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1