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

Model Number 9735602

Device Problem Environmental Compatibility Problem (2929)

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

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9735634, serial/lot #: (b)(4).The power supply was returned to the manufacturer for analysis.The returned power supply had normal output when connected to ac.No problem found.A medtronic representative went to the site to test the equipment.It was reported that the power supply of the navigation system was replaced and the software was uninstalled/re-installed.The hardware and instruments passed the system checkout.The system 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 that was used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the system shut down unexpectedly during the procedure.There was a reported delay of less than one hour.There is no known impact on patient outcome.On 2020-mar-05 additional information received.It was reported that while on site to troubleshoot, the manufacturer representative could not replicate the issue.Software was uninstalled/reinstalled.Per site, the system will randomly shut down while plugged in and have to boot it up.The other navigation system at this site is used in the same operating room and does not have the same behavior.Probable cause of the issue was determine to be faulty power supply.On (b)(6) 2020 it was reported that after the site restarted the system, they were able to use it to complete the process.

• 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: 9878585
• MDR Text Key: 184917188
• Report Number: 1723170-2020-01058
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/25/2020
• 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: 66 YR