MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Model Number	9735016
Medical Device Problem Codes	Device Sensing Problem (2917); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: when connected to a know good system, the returned malleable suction was not able to track displaying red status only.A check of the emitter interface showed that coil #3 was dead.An electrical failure was confirmed.H10: 1723170-2024-01389 references the system involved in this event.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 an imaging system being used in an unknown procedure.It was reported that the site was having trouble verifying both the straight suction and disposable malleable suction.Once verified the site continued the case but after 45 minutes all instruments stopped tracking.The representative performed troubleshooting on 2024-5-9.They recreated the issue with the same malleable suction used during t the issue occurrence.The instrument would register that it was connect to the system but would not track.A plug n play registration probe was able to be tracked without issue.The em diagnostics were checked and all statues were reported as expected, all ports recognized when an instrument was connected and the port with the malleable suction reported "connected -tool_3.The site discarded the instrument tracker that was used with the straight suction, and the representative did not have access to the straight suction.The representative was unable to recreate the issue of all instruments not tracking after having the system on for >45 minutes.
Additional Manufacturer Narrative
H2) please see section a1-3, section b5, and the additional codes section for the additional 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.
Event or Problem Description
Additional information was received.The procedure being performed was a functional endoscopic sinus surgery (fess), there was a less than 30 minute surgical delay, and there was no impact to the patient's outcome.

• Common Device Name: EAR, NOSE, AND THROAT 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: 19646721
• Report Number: 1723170-2024-01612
• Device Sequence Number: 20674633
• Product Code: PGW
• UDI-Device Identifier: 00643169443518
• UDI-Public: 00643169443518
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K133665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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 Expiration Date: 02/05/2025
• Device Model Number: 9735016
• Device Catalogue Number: 9735016
• Device Lot Number: 230206E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 47 YR
• Patient Sex: Male