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

Model Number 9736242

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

A manufacturer rep went to the site to test the system.The system passed the system checkout.Software analysis was performed.Logs were reviewed.Three session logs were available.In two sessions, application did not boot up and got stuck at splash screen."got services ready" and "hiding splash screen" messages were not available in these sessions which indicate that system got stuck at splash screen.After the reboot, application got launched successfully which could be seen from third session logs.The issue is consistent with a known software issue.Concomitant medical products: other relevant device(s) are: product id: 9 736226, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the site brought their navigation system into the or room and it would not fully boot into the software.It was rebooted and came up normally.No patient was present.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12315550
• MDR Text Key: 266303323
• Report Number: 1723170-2021-02072
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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
• Date Manufacturer Received: 07/22/2021
• 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