MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION ENT NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9733560XOMR
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight not available from the site.No parts have been received by the manufacturer for evaluation.Device manufacture date is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while in a functional endoscopic sinus surgery (fess), an imprecision was observed.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
A software investigation was initiated.The archives were reviewed but provided no additional insight regarding the cause of reported complaint.Unable to determine probable cause without further information since the on-going investigation proved to be inconclusive based on the information provided.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the site opted to complete the procedure without the navigation system.Additionally, the procedure was delayed by about ten minutes due to the reported issue and that the imprecision was estimated to be 6 millimeters.

• Brand Name: FUSION ENT NAVIGATION SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8726797
• Report Number: 1723170-2019-03763
• Device Sequence Number: 13874200
• Product Code: HAW
• UDI-Device Identifier: 00613994594235
• UDI-Public: 00613994594235
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2019

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 Model Number: 9733560XOMR
• Device Catalogue Number: 9733560XOMR
• Device Lot Number: 4500965801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 07/03/2019; 09/13/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 07/31/2019; 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR