MAUDE Adverse Event Report: NUVASIVE NUVASIVE EMG ENDOTRACHEAL TUBE; NEUROSURGICAL NERVE LOCATOR

Model Number	2010380
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as product was discarded by the facility.Root cause was unable to be identified.
Event or Problem Description
On (b)(6) 2019 patient underwent a total thyroidectomy procedure in which a nuvasive nv et tube was utilized.It was reported that the et tube's cuff was not holding pressure during procedure.The et tube was replaced and the issue was resolved.No patient injury reported.

• Brand Name: NUVASIVE EMG ENDOTRACHEAL TUBE
• Common Device Name: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 8384785
• Report Number: 2031966-2019-00166
• Device Sequence Number: 19345607
• Product Code: PDQ
• UDI-Device Identifier: 00887517161390
• UDI-Public: 887517161390
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2019

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 Model Number: 2010380
• Device Lot Number: 1812006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 73