MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MAIN CART 9735669 STEALTH S8 EM ENT; INSTRUMENT, STEREOTAXIC

Model Number 9735669

Device Problem Output Problem (3005)

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

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

No parts have been returned for analysis.Other relevant device(s) are: product id: 9735736, serial/lot #: unk.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).The system was slow to load an exam from the site and became unresponsive.The site rebooted the system and was able to load the exam.After this, during registration, the initialization bar was taking a long time to fill up.The surgeon stopped tracing and the system was behaving as if the trace was not completed, but right when the surgeon was going to restart the trace, the registration metric appeared and they could advance into navigation.While navigating, the probe and two suctions verified, but then the system would not track the instruments.The case was continued with a malleable suction and traceable blade without any issue.After the case the representative could replicate the tracking issue with the instruments, but then did a system reboot and the issue was resolved.The representative also upgraded the software to the most current version.There was no reported delay and no impact to patient outcome.

Manufacturer Narrative

The system was serviced in the field.It was noted that hardware parts were replaced.The system passed all tests and was performing as intended.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Software analysis was inconclusive as to the root cause of the reported behavior with the provided information.With respect to the report of the initialization bar talking too long to fill, the provided scan contained significant surface anatomy that was not utilized.Registration trace points also focused in one area, which may cause the initialization process to take longer than expected.Registration was completed with a metric of 1.6mm.The recommendation would be to collect points more posterior and superior anatomy that was included in the scan.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAIN CART 9735669 STEALTH S8 EM ENT
• 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: 9375768
• MDR Text Key: 181229985
• Report Number: 1723170-2019-05783
• Device Sequence Number: 1
• Product Code: HAW
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• 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: 04/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2018
• 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: 40 YR
• Patient Weight: 95