MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC LINEAR BLUNT PROBE HC; INSTRUMENT, STEREOTAXIC

Model Number	9733879
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The active blunt probe was returned to the manufacturer for analysis, and through analysis the issue was able to be duplicated.The returned probe had no color and the leds appeared to be glazed over.When connected to a known good system it was found that led #3 was not firing.Otherwise, the probe returned good geometry and divot error readings.It was determined that there was an electrical failure with the returned probe.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 the site had a damaged active blunt probe.One led light of the probe's long cable went out.There was no patient present when this issue was observed.It could not be determined if the instrument passed verification.

• Brand Name: LINEAR BLUNT PROBE HC
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8067493
• Report Number: 1723170-2018-05647
• Device Sequence Number: 2701825
• Product Code: HAW
• UDI-Device Identifier: 00613994480613
• UDI-Public: 00613994480613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2018

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: 9733879
• Device Catalogue Number: 9733879
• Device Lot Number: 150626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1