MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION ENT NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9733560XOM
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No products have been returned to medtronic for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery (fess).It was reported that the screen was blank and they were not seeing their ct after registration.Technical services (ts) clarified that they were in the registration tab, they successfully completed their registration with a tracer probe and it said to verify registration accuracy with known anatomical points.The site was able to advance to the navigation screen.On the navigation screen, the emitter details showed nipt 0.2 geometry error, straight suction at 1.23.When surgeon placed instrument in divot, "nothing happened." technical services (ts) advised to see if they could navigate with any other instruments, specifically the tracer pointer.The registered nurse (rn) denied being able to navigate with pointer stating "no instruments work." ts asked if there was another suction to try, rn stated that they had tried them all.The surgeon declined further troubleshooting help and navigation was aborted, and had nurse end call. there was a reported delay to the procedure of 15 minutes.There was no reported impact to the patient.Additional information was received.It was reported that the scans were dark, they just needed to adjust the contrast to be able to see the scan during navigation.The site had a new ct scan, so the local representative (ent) instructed them how to get the scan in view.Additional information was received.It was reported that the resolution was discovered on a later surgery.Once the site adjusted the contrast, the issue had been resolved.

• Brand Name: FUSION ENT NAVIGATION SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11770195
• Report Number: 1723170-2021-01189
• Device Sequence Number: 3157591
• Product Code: HAW
• UDI-Device Identifier: 00643169518452
• UDI-Public: 00643169518452
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• 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): 05/04/2021

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 Model Number: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1