MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9733856R S7 STAFF REWORK 110V; INSTRUMENT, STEREOTAXIC

Model Number	9733856R
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Onsite functional and visual examination was performed by a manufacturer representative.The csu and it i/o hub was replaced and the issue was resolved.The system passed a system checkout and was returned to an operational condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that after replacing the computer the rep was adding tool cards and the camera stated localizer not connected.She stated that the left light was flashing green, then the second light was solid green and there was no amber light.She stated the polaris spectra system control unit (scu) only had 2 green lights not 3.After replacing the csu the camera showed green leds, but the ndi toolbox would not connect.The scu was showing a solid amber fault light and the power indicator on the left side was flashing amber.Technical services (ts) had the rep bypass the usb connection on the i/o hub directly into the scu and move the power cable port on the ups with no change.The rep checked all the computer connections with a with another working navigation system and everything was correct.Ts had the rep check for light on the inside of the i/o circuit board and the rep could not see any lights.The software was displaying localizer disconnected and was showing the surgeon monitor as disconnected.
Additional Manufacturer Narrative
Both the polaris spectra system control unit (scu) and the i/o hub were returned for analysis.Functional testing found that both parts were functioning as designed.

• Brand Name: CART 9733856R S7 STAFF REWORK 110V
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8503676
• Report Number: 1723170-2019-01676
• Device Sequence Number: 19167650
• Product Code: HAW
• UDI-Device Identifier: 00613994603678
• UDI-Public: 00613994603678
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: No Information
• Device Model Number: 9733856R
• Device Catalogue Number: 9733856R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1