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

Model Number	9733560
Medical Device Problem Codes	Device Sensing Problem (2917); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.A22: registration erased, emitter field too small a0709: instruments not tracking as expected d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9733467, software version#: 2.3 product id: 9733467, software version#: 2.3 h3, h6: the system was serviced in the field.No failures were found.Codes b01, c19, and d14 are applicable.H3, h6: software analysis was performed.It was found that there was insufficient information to determine whether a software anomaly contributed to the event.Codes b01, c19, and d15 are applicable.H3, h6: software analysis was performed.It was found that there was insufficient information to determine whether a software anomaly contributed to the event.Codes b01, c19, and d15 are applicable.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).It was reported that the emitter field was "very small" and the instruments were not tracking as expected.The representative on site reported that registration was completed successfully and accuracy was verified.Then mid-way through the procedure when switching to the 70 degree curved suction instrument, the rep reported that the surgeon touched appx.4 cm away from the patient tracker and the system registered that the back button had been touched "several times".The rep reported that this caused the registration to be "erased" and the surgeon had to re-register the patient.The procedure continued without another incident of this nature, however the rep reported that throughout the entire procedure the emitter field remained "very small".There was no impact on patient outcome.It was noted that there were no exterior metal in the field.Additional information received reported that there was less than 1 hour delay in the surgical procedure.

• Brand Name: FUSION® ENT NAVIGATION SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21333694
• Report Number: 1723170-2025-00504
• Device Sequence Number: 11701964
• Product Code: HAW
• UDI-Device Identifier: 00643169504394
• UDI-Public: 00643169504394
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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: 9733560
• Device Catalogue Number: 9733560
• Device Lot Number: N07350986
• 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: 11/29/2022
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female