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

Model Number 9736242

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2023

Event Type  malfunction  

Event Description

Medtronic received information regarding a navigation device being used during a functional endoscopic sinus surgery (fess) procedure.It was reported that when turning on the system (patient was not in the room when this happened), it would boot to a black screen after signing into the customer side.Admin was in the right hand corner.After rebooting the system 3 times, they signed into admin.They shut the system down restarted it then she was able to sign into the customer side.During the case, the doctor was not actively navigating at this time, the screen went black and went back to the tracking screen.On the top right of the screen, there were double arrows and before she could tap on the double arrows, it went back to the navigation screen.There was no impact on the patient's outcome.There was no delay to the procedure.

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9736226, serial/lot #: 2.0.1, ubd: , udi#: ; product id: 9736226, serial/lot #: 2.0.1, ubd: , udi#: ; product id: 9736218, serial/lot #: (b)(6), ubd: , udi#: h3,h6: a medtronic representative went to the site to test the equipment.Testing revealed that the ssd was replaced.The imaging sy stem then passed the system checkout and was found to be fully functional.Codes b01,c07,d02 are applicable.H3,h6: a hardware analysis was initiated for 9736218 to determine the probable cause of the reported behavior.Analysis found that there were no failures found.The ssd did 5 successful reboots with logins.Found an application that was previously installed, and it functioned normally without failure.S.M.A.R.T data; self-test reported no errors on the drive.The drive functioned normally without failure.Codes b01,c19 ,d14 are applicable.H3,h6: a software analysis was initiated for the 'screen went blank' allegation, to determine the probable cause of the reported behavior.Analysis found that the issue was consistent with a previously known and tracked software anomaly.The logs were reviewed and it was observed that for the initial 2 session there was an issue with connecting to the database.It was noted that this was suspected that due to this, the screen went blank.Codes b01,c10,d02 are applicable.H3,h6: a software analysis was initiated for the 'screen went blank to navigating screen' allegation, to determine the probable cause of the reported behavior.Analysis found that there was insufficient information to determine if the issue came from a software anomaly.The logs were reviewed and one session was observed that only once navigated to the navigation screen from the verify registration screen.There was no other evidence captured in the logs for the cause of blanking screen and went back to tracking navigation screen.There were no other errors captured in the logs while user doing navigation or related to navigation.Codes b01,c19,d15 are applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION FLEXENT
• Type of Device: 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18052165
• MDR Text Key: 327154567
• Report Number: 1723170-2023-02124
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/01/2023

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
• Device Operator: Health Professional
• Device Model Number: 9736242
• Device Catalogue Number: 9736242
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 82 KG