MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STRAIGHT SUCTION, AXIEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733449
Medical Device Problem Codes	Imprecision (1307); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medtronic representative went to the site to test the navigation system used during the procedure.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect straight suction has not been provided by the manufacturer for evaluation.
Event or Problem Description
A medtronic representative reported that, while in a functional endoscopic sinus surgery (fess), the surgeon felt an imprecision when using the straight suction.All other instruments were accurate.The distance to divot was reported to be within acceptable limits and the tracker was reseated without resolution.The surgeon opted to continue the procedure with the suspect suction.No additional information was provided.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.
Additional Manufacturer Narrative
The suspect suction was returned to the manufacturer for analysis.The suction was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• Brand Name: STRAIGHT SUCTION, AXIEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6538184
• Report Number: 1723170-2017-01879
• Device Sequence Number: 11079672
• Product Code: HAW
• UDI-Device Identifier: 00643169702851
• UDI-Public: 00643169702851
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2017

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 Catalogue Number: 9733449
• Device Lot Number: 17011221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 68