MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. EM ENT STRAIGHT SUCTION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9733449
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3,h6) no parts have been received by the manufacturer for evaluation.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the straight suction was unable to track consistently throughout navigation with a flat emitter.It was confirmed the the issue only occurs with the straight suction instrument.The issue occurred across different straight suctions and instrument trackers.The instrument could be verified but had issues tracking in navigation until further entered into the sinus.There was no metal interference.The site put towels between the emitter and the non-metal bed.This resulted in a delay of less than one hour.There was no impact on patient outcome.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received.It was reported that the rep went back to the site and tested two of their three trays.He examined each instrument in the two sets.Each one side by side characteristically were almost identical.Each time the rep raised the instrument about 12 inches from the emitter, it would go to red status.After testing the sets with same results, the rep stated the emitter field might be smaller than it should be.
Additional Manufacturer Narrative
H2: please see section b5 for additional information.H2: please see section d4 for device lot number and full udi.H2: please see section h4 for device manufacturing date.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the flat emitter range for the longer instruments seemed to lose tracking the higher up the emitter went, even though tracking typically works at that height.It was noted the instruments verify at over 2.4 the max was 3.5.The manufacturer representative tested the instruments with the side emitter, and they also still verified at a higher geometry error.It was not over the geometry error, but the instrument would lose how far away it can be from the emitter.
Additional Manufacturer Narrative
H2: the navigation system being used with the straight suction was checked out with no noted issues.The straight suction is the suspected cause of the issue.Section e3 was updated with initial reporter information.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EM ENT STRAIGHT SUCTION
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23617302
• Report Number: 1723170-2025-03784
• Device Sequence Number: 15716243
• Product Code: HAW
• UDI-Device Identifier: 00763000053369
• UDI-Public: (01)00763000053369(11)240913(10)240913
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/25/2026

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: 9733449
• Device Catalogue Number: 9733449
• Device Lot Number: 240913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 12/01/2025; 02/19/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 11/26/2025; 12/03/2025; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 131 KG