MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STRAIGHT SUCTION, AXIEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733449
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.The issue was determined to be damage to the straight suction.The suction was returned to the manufacturer for analysis.The returned suction was unable to verify when attached to a known good tracker.The suction determined to be the cause of the issue.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess).It was reported that the surgeon did not feel very accurate after verifying the straight suction at 1.9 mm.There was no impact to patient.There was a reported delay to the procedure of less than 1 hour due to this issue.
Additional Manufacturer Narrative
A medtronic representative went to the site to test the navigation system used adjacent to the suspect suction.Testing revealed that the navigation system functioned as designed.The system then passed the system checkout and was found to be fully functional.
Additional Manufacturer Narrative
Correction: initial reporter.Additional information: the surgery was completed using the straight probe.This inaccuracy was discovered prior to incision.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRAIGHT SUCTION, AXIEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7841716
• Report Number: 1723170-2018-04360
• Device Sequence Number: 13944844
• Product Code: HAW
• UDI-Device Identifier: 00763000053369
• UDI-Public: 00763000053369
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 9733449
• Device Lot Number: 18012398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 09/04/2018; 12/12/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 09/10/2018; 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1