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

Model Number 9735602

Device Problem Mechanical Problem (1384)

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

Event Date 07/31/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.The unique identifier was not known at the time of reporting.The manufacturer representative went to the site to test the navigation system.The reported issue was confirmed and parts were replaced.No parts have been received by the manufacturer for evaluation.The manufacture date was not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess).It was reported that the software was showing localizer not connected.The manufacturer representative (rep) brought in another axiem box and emitter and they were able to proceed with the case.There was less than an hour delay in the case.No impact on patient outcome.The rep stated that the axiem box showed a red 8 and the emitter wasn't chirping.They rebooted the system and the axiem box showed a red 7 with a non-chirping emitter.It was requested that they try another axiem box with the emitter.The new axiem box showed a red 8 and the emitter wasn't chirping.Another update from the rep stating after receiving the emitter and connecting the system in several different boot up configurations, the system still did not recognize the axiem box.The axiem box had a continuous red 8 and did not alter back and forth as it did previously.The rep then took the new emitter and another axiem box from a different system and connected it and it functioned as intended.

Manufacturer Narrative

The generator was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.The reported problem could not be duplicated.The field generator was connected to a test system for a multi-day burn-in test.The system remained in green status during all testing.Flexing the cable did not indicate any intermittent opens.Fully functional.No failure found.The emitter was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.The reported problem could not be duplicated.The emitter was connected to a test system with the ent application for a overnight burn-in test.Registration, tracking, and accuracy looked normal on all 8 tool ports.The connected / disconnected the tools from each port multiple times and system remained functional.No failure was found.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Patient information received and added.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: 8920443
• MDR Text Key: 155197124
• Report Number: 1723170-2019-04587
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 77