MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number FUSION

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

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

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The computer was returned to the manufacturer for analysis. Analysis found that system passed sys test and all refurbishment requirements. Analysis found that there was no fault with the system.

Event Description

Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess) procedure. It was reported that intraoperatively during the navigation task, the software jumped back to the select patient screen again. This occurred approximately 1. 5 hours into the case. The frazier suction was inside the patient¿s nose when the system jumped back. It was confirmed with the manufacturer representative that the site had reinstalled the software since the last case where a similar issue occurred. This issue resulted in a delay of surgery of less than 1 hour, and there was no impact on patient outcome.

• Brand Name: FUSION NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: tiberious mose ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7580939
• MDR Text Key: 110453545
• Report Number: 1723170-2018-02600
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: FUSION
• Device Catalogue Number: 9733560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse