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

Model Number 9736242

Device Problems Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

H3) onsite functional and visual examination was performed by a manufacturer representative.The monitor was replaced due to visible damage.The system passed a system checkout and was returned to an operational condition.The ssd and computer were also replaced.Analysis of the computer and ssd determined they were functioning as designed.A software analysis was performed.Software analysis determined that the cause of the issue was due to a software malfunction causing the reported event.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9 736226, serial/lot #: 2.0.1, sfw kit 9736226 stealth flex ent ssd 9736218 2.5in 480gb duped svc computer 9736217 aio flex ent svc rfb 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery (fess) procedure.It was reported that an error message popped up while registering that said "internal error has occurred - error 64" and it occurred 3 times during the case.Each occurrence happened during registration in the software while the site was tracing.After the 4th reboot, the site was able to get the system up and running and complete the case.There was no impact on patient outcome and the issue caused a less than 1 hour delay.It was noted that the probable cause may be from a corrupt registration model, the patient was deleted and the image were re-imported.

• 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: 19006651
• MDR Text Key: 339322310
• Report Number: 1723170-2024-00950
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2024

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
• Device Operator: Health Professional
• Device Model Number: 9736242
• Device Catalogue Number: 9736242
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 03/29/2024
• 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 H11...."
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 73 KG