MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735602

Device Problem Human-Device Interface Problem (2949)

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

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.No parts have been replaced or returned for analysis.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 power on the system was turned on, but there was an recognition failure in the magnetic field due to an emitter error.It was recognized finally after restarting three times.The same issue recurred even though the product was just recently replaced with a new one due to the same issue.There was less than an hour delay in the case.No impact on patient outcome.Additional information received nothing that there was a communication failure with the em control box.The usb port of the em control box was cleaned with a cotton swab moistened with alcohol.After that, the issue resolved.

• Brand Name: MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM
• Type of Device: EAR, NOSE AND THROAT 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 10154695
• MDR Text Key: 195247932
• Report Number: 1723170-2020-01665
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153247
• 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
• Report Date: 06/15/2020

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: No
• 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