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

Model Number 9735669

Device Problems Imprecision (1307); Human-Device Interface Problem (2949)

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

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9735736 (software version: (b)(4)).A medtronic representative (rep) went to the site to test and service the equipment.The rep was unable to reproduce any errors or issues reported by the site; the rep was unable to replicate the inaccuracy or the instrument fault error.Each instrument in the site's tray was tested by the rep and was functioning as expected.It was indicated that the failure was resolved.A system checkout was completed and the navigation system was operational.No hardware parts were replaced on the system.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess).It was reported that after receiving an "instrument fault" error several times with different instruments, registration passed.The site was approximately 2-3 inches inaccurate laterally while navigating to known anatomical landmarks.The site swapped instruments as well as the patient tracker, and the system was rebooted, but the issue did not resolve.Navigation was aborted due to this issue.There was a surgical delay of less than 1 hour, and there was no impact on patient outcome.

Manufacturer Narrative

A software analysis was initiated.Software analysis was unable to determine the cause of the event based on the provided information.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 EM ENT SYSTEM
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8919025
• MDR Text Key: 155173059
• Report Number: 1723170-2019-04582
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• 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: 10/08/2019
• 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: 31 YR
• Patient Weight: 64