MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735602

Device Problem Installation-Related Problem (2965)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.No parts have been returned to the manufacturer for analysis.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a clinical specialist (cs) regarding a navigation device.It was reported that after installing the device the tool cards would load but the image of the tool would not display.The cs then went into registration and the system would not recognize any instruments that were plugged in.The cs rebooted the device multiple times to clear this and then went to install tools 7, but the system would not accept the media.There was no patient involvement.

Manufacturer Narrative

The computer was sent to the vendor for analysis.Vendor analysis found that the failure could not be confirmed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation: additional vendor analysis results became available.The vendor confirmed the failure.The vendor confirmed the usb's will not work in the operating system (os).The unit was reloaded with a test os and the problem went away.The unit was then ran through the production process.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The navigation system passed the system checkout and was found to be fully functional.The device was returned and analysis found that at initial power up the computer would not communicate with a known good axiem.After several reboots, communication was established.The installed tools would not track and the installed tool cards did not display the tools.Troubleshooting the components involved suggested possible intermittent usb ports.It was determined that the computer components were damaged or failing.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION COMPACT
• 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: 8236853
• MDR Text Key: 132918820
• Report Number: 1723170-2019-00205
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Device Lot Number: 2094442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 01/14/2019; 02/26/2019; 07/17/2019
• Supplement Dates FDA Received: 02/01/2019; 03/23/2019; 08/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1