MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MALLEABLE SUCTION SMALL, STANDARD TIP; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number	9735015
Medical Device Problem Codes	Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation, thus no analysis can be done at this time.
Event or Problem Description
A site representative reported that during an ear, nose, and throat procedure, a malleable suction instrument was unable to be tracked by the navigation system.The instrument tracker was replaced and the issue was resolved.The procedure was completed successfully with the suction and the navigation system after a delay of less than one hour.The patient was not impacted.
Additional Manufacturer Narrative
Device expiration date now provided.Device manufacturing date now provided.

• Brand Name: MALLEABLE SUCTION SMALL, STANDARD TIP
• Common Device Name: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6031585
• Report Number: 1723170-2016-02610
• Device Sequence Number: 16210887
• Product Code: PGW
• UDI-Device Identifier: 00643169443501
• UDI-Public: 00643169443501
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K133665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2016

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: Physician
• Device Expiration Date: 12/20/2016
• Device Catalogue Number: 9735015
• Device Lot Number: 141231DR
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2016
• Supplement Report FDA Received Date: 12/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1