MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NUVENT¿; INSTRUMENT, ENT MANUAL SURGICAL

Model Number 1830617FRT

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.It was reported that the breakout out box was replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.Instrument analysis is pending.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system that was used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the breakout box light was yellow to start the case so the site unplugged and re-plugged it and it worked.When they attempted to use the 98 degree balloon, the light was again yellow so they tried other ports but it still never changed to green.They then unplugged the breakout box and plugged it back in.The balloon stayed yellow but everything else was green.It would not work at all and it didn¿t recognize anything even though the light was green.The site then turned off the system, unplugged the breakout box and plugged it back in then turned the system back on.However, the balloon was still yellow though everything else was green.The system worked, so they opened a new balloon and then the light turned green.This resolved the issue.There was no known impact on patient outcome.The issue resulted in less than one hour procedure delay.

• Brand Name: NUVENT¿
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9525723
• MDR Text Key: 175931651
• Report Number: 1045254-2019-00706
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00643169770942
• UDI-Public: 00643169770942
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132297
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2020
• Device Model Number: 1830617FRT
• Device Catalogue Number: 1830617FRT
• Device Lot Number: 0216410406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2018
• 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