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

Model Number 9736242

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/12/2024

Event Type  malfunction  

Event Description

Medtronic received information regarding an imaging system being used intra-operatively during a functional endoscopic sinus surgery (fess) procedure.It was reported that there was an alleged inaccuracy.It was displayed that the surgeon was inside the eyeball when they were not.Everything else was accurate.No known impact to patient outcome.There was a surgical delay of less than one hour.Troubleshooting was performed, registration was not the best just small tracing on the forehead.The doctor did not reregister.Accuracy was inaccurate around the eyeball.

Manufacturer Narrative

H2) continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735736, version #: 2.1.0 h3) no parts have been received by the manufacturer for evaluation.  codes: b17, c20, d15 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.

Manufacturer Narrative

H2-3) a manufacturer representative went to the site to test the navigation system.No hardware parts were replaced and the system p performed as intended.Codes: b01, c19, d14 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.

• 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: 19115279
• MDR Text Key: 340268532
• Report Number: 1723170-2024-01081
• 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,Followup
• Report Date: 05/13/2024

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: 04/12/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/13/2024
• 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...