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

Model Number 2010380

Device Problem Deflation Problem (1149)

Patient Problem Extubate (2402)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation as product was discarded by the facility.Root cause was unable to be identified.

Event 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
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: yobana sanchez ; 7475 lusk boulevard; san diego 92121 ; 8589093383
• MDR Report Key: 8384785
• MDR Text Key: 139049768
• Report Number: 2031966-2019-00166
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517161390
• UDI-Public: 887517161390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 2010380
• Device Lot Number: 1812006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 73