MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S7; INSTRUMENT, STEREOTAXIC

Model Number	9733533
Medical Device Problem Codes	Material Integrity Problem (2978); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter not known at the time of reporting.H3,h6) no parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess).It was reported that the system began recognizing the registration probe with the instrument tracker as a microdebrider.The microdebrider was unplugged from the system but the registration probe would not reverify.The site rebooted the system and the issue still occurred.The site switched to a fusion system and the system struggled to verify the registration probe and did not track well, the site switched to use a straight probe and the site was able to successfully continue with the procedure.There was less than an hour delay in the procedure.No impact on patient outcome.
Additional Manufacturer Narrative
The manufacturer representative went to the site to test the navigation system.A system checkout was performed and the system is working as intended.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess).It was reported that the system began recognizing the registration probe with the instrument tracker as a microdebrider.The microdebrider was unplugged from the system but the registration probe would not reverify.The site rebooted the system and the issue still occurred.The site switched to a fusion system and the system struggled to verify the registration probe and did not track well, the site switched to use a straight probe and the site was able to successfully continue with the procedure.There was less than an hour delay in the procedure.No impact on patient outcome.
Additional Manufacturer Narrative
Additional information added to the event description.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Update from the manufacturer representative (rep) there were no issues verifying instruments.The rep spoke with a frequent user health care professional and they stated they have had no more issues with any instruments.

• Brand Name: S7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8228144
• Report Number: 1723170-2019-00153
• Device Sequence Number: 2267032
• Product Code: HAW
• UDI-Device Identifier: 00643169702837
• UDI-Public: 00643169702837
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2019

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: 9733533
• Device Catalogue Number: 9733533
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/12/2019; 02/07/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 02/01/2019; 02/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1