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

Model Number	9733533
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.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), the site had issues with an instrument tracker.It was reported that during patient registration, the tracker signal was lost on the emitter.However, registration was completed without issue.It was reported that the tracker could not be recognized when the surgeon attempted to navigate a suction.It was reported that the surgery was performed with a navigation blade that did not have issues.There was no reported delay to the procedure due to this issue.There was no reported impact on patient outcome.After the procedure, troubleshooting identified that the instrument tracker caused the issue as it did not appear correctly in the emitter field of view.

• Brand Name: ENT INSTRUMENT TRACKER
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10190717
• Report Number: 1723170-2020-01750
• Device Sequence Number: 19069614
• Product Code: HAW
• UDI-Device Identifier: 00613994353450
• UDI-Public: 00613994353450
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2021
• Device Model Number: 9733533
• Device Catalogue Number: 9733533
• Device Lot Number: 191114E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1