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

Model Number	9733533XOM
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during patient registration.It was reported that two instrument trackers and the microdebrider were plugged into the system and when attempting to insert the probe into the divot of the patient reference frame, the navigation system only recognized the microdebrider.The microdebrider was then unplugged and the navigation system would not recognize the two trackers.The application software was exited, another tool was tested and the navigation system functioned as designed.There was a reported delay to the procedure of five minutes due to this issue.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was the instrument tracker that caused the issue and was resolved when a new tracker was plugged into the system.

• 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: 8795371
• Report Number: 1723170-2019-04107
• Device Sequence Number: 1876984
• Product Code: HAW
• UDI-Device Identifier: 00613994380012
• UDI-Public: 00613994380012
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• 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
• Report Date (Section B): 09/03/2019

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 Expiration Date: 02/17/2021
• Device Model Number: 9733533XOM
• Device Catalogue Number: 9733533XOM
• Device Lot Number: 190218B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 82