MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 EM ENT SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9735668
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 for a functional endoscopic sinus surgery (fess).It was reported that intra-operatively, the site was tracing and were not getting points on the side of the face farthest from the emitter.A manufacturer representative tried re-positioning and holding the emitter while the trace was happening, however, it was not possible to get that side.The procedure was completed without the use of navigation.There was no reported impact to patient outcome.There was a reported delay to the procedure of less than one hour due to this issue.The site had edited the 3d model and had also auto-refined.
Additional Manufacturer Narrative
The software investigation was unable to determine the probable cause of the reported issue.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 for a functional endoscopic sinus surgery (fess).It was reported that intra-operatively, the site was tracing and were not getting points on the side of the face farthest from the emitter.A manufacturer representative tried re-positioning and holding the emitter while the trace was happening, however, it was not possible to get that side.The procedure was completed without the use of navigation.There was no reported impact to patient outcome.There was a reported delay to the procedure of less than one hour due to this issue.The site had edited the 3d model and had also auto-refined.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received additional information that the archive was reviewed.It contained multiple registrations that displayed a metric but failed to load when selected, showing registration failed.One registration was able to load and the pattern was good for the exam.The exam field of view (fov) was low with much of the head missing.
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that the system was performing as intended.No issues were found.The system passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 EM ENT SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8262692
• Report Number: 1723170-2019-00330
• Device Sequence Number: 1617189
• Product Code: HAW
• UDI-Device Identifier: 00643169877016
• UDI-Public: 00643169877016
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K162309
• 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,Followup,Followup,Followup
• Report Date (Section B): 05/15/2019

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: 9735668
• Device Catalogue Number: 9735668
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 01/23/2019; 02/27/2019; 05/13/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 02/14/2019; 03/13/2019; 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 113