MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 EM ENT SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9735669

Device Problem Imprecision (1307)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9735736, version #: (b)(4).A medtronic representative went to the site to test the equipment.It was reported that the issue could not be confirmed or replicated, no components were replaced.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an navigation system being used for a functional endoscopic sinus surgery (fess) procedure.During the procedure, the surgeon felt there was a 3mm inaccuracy towards the right.There was a registration metric of 2.2 with both yellow and a green zone of accuracy (green area was small).Upon re-registration, an error metric of less than 2.2 was obtained.The surgeon felt better with the re-registration accuracy.However, the surgeon did not indicate they still felt inaccurate after re-registration.The procedure was completed without aborting imaging or navigation.There was no reported impact to the patient.The issue resulted in less than one hour procedure delay.The navigation system auto-guide was not used during the procedure.It was noted the imaging was taken the day or surgery.No complications were reported/anticipated.

Manufacturer Narrative

A software analysis was initiated to determine the probable cause of the issue.Analysis was unable to determine probable cause without further information since the on-going investigation proved to be inconclusive based on the information provided.This case may be re-opened if additional information is received.Suspecting poor registration technique.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 EM ENT SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9179563
• MDR Text Key: 173292458
• Report Number: 1723170-2019-05190
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169838918
• UDI-Public: 00643169838918
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735669
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2017
• 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
• Patient Age: 14 YR
• Patient Weight: 83