MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9735665
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
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 site were losing accuracy.Straight suction exploring skull base in fnoids medially and laterally.It would come and go.Straight suction would stay plugged in and the doctor would put it to the side and then when bringing it back into the field they would have to reverify.The second straight suction that they used was also having a hard time verifying.The manufacturer representative noticed metal rails underneath the bed near the bed.This occurred intraoperatively, and there was a surgical delay of less than one hour.There was no reported impact to patient outcome.
Additional Manufacturer Narrative
H3, h6: a medtronic representative went to the site to test the equipment.Testing revealed that the straight suction was removed from the ent navigation system sets.B01, c13, d02 are applicable.H6: multiple fdd/annex a codes were reported.A0709 was coded for the surgeon putting straight suction to the side and then when bringing it back they had to reverify, and difficulty verifying second straight suction.A0908 was coded for the system losing accuracy.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.
Additional Manufacturer Narrative
H2) continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735762, version #: 2.1.0 h2) please see section b5 and a3a-4 for further 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.There was a 5-10 millimeter inaccuracy.
Additional Manufacturer Narrative
A software analysis was performed.It was determined there was insufficient information to determine the cause of the 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.

• Brand Name: STEALTHSTATION¿ S8 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19383308
• Report Number: 1723170-2024-01341
• Device Sequence Number: 11711817
• Product Code: HAW
• UDI-Device Identifier: 00763000359898
• UDI-Public: 00763000359898
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162309
• 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,Followup,Followup
• Report Date (Section B): 09/17/2024

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 Model Number: 9735665
• Device Catalogue Number: 9735665
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 05/23/2024; 08/21/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/07/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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 Sex: Female
• Patient Weight: 61 KG