MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9733560

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.Testing revealed that the issue could not be reproduced.The system 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 a navigation system being used for a functional endoscopic sinus surgery (fess).It was reported that pre-operatively, after the system was started, the screen became pitch dark when the product was left unattended.When rebooting the product, "no signal" was displayed and the screen was pitch dark.Use of the product was abandoned.The procedure was completed and there was no reported impact to patient outcome.There was no reported surgical delay.An inspection was performed, but no reproducibility was observed.

Manufacturer Narrative

Medtronic received additional information that it was decided to replace the computer.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The computer has been received by the manufacturer.However, analysis has not been completed at the time of filing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The computer was returned to the manufacturer for analysis.Analysis found that the reported issue could not be duplicated.No failure was found with the returned computer.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A manufacture representative went to the site and inspected the system.The computer was replaced and the issue resolved.A system checkout was performed after part replacement and all tests passed.If information is provided in the future, a supplemental report will be issued.

Event Description

Confirmed the lot number provided was for the computer that was installed as a replacement.The lot number has been removed from pli 20.The lot number for the computer that was replaced was confirmed as unknown.

• Brand Name: FUSION¿ ENT NAVIGATION 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: 8991653
• MDR Text Key: 159600104
• Report Number: 1723170-2019-04839
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733560
• Device Catalogue Number: 9733560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2016
• 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