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

Catalog Number	9733449
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier not available from the site.Patient age not available from the site.Patient weight not available from the site.During the onsite inspection, the medtronic representative reported that when testing the instrument after the case, the straight suction was able to verify and track fine.No issues were found.
Event or Problem Description
A medtronic representative reported that the site had registered the patient twice and were accurate on the skin, but when entering the nose during the case, there was an inaccuracy.The site had a good tracing pattern and the exam quality was fine.The medtronic representative arrived and re-traced the patient but was having difficulty verifying the straight suction; it had a higher distance to divot.The site was eventually able to verify the straight suction, but it was again off by 1mm.The site then brought other instruments into the field which were accurate, but the suction wasn't.The physician took into account the inaccuracy and proceeded with the surgery.There was no patient impact reported and the delay in surgery was less than an hour.

• 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: 6490489
• Report Number: 1723170-2017-01555
• Device Sequence Number: 978949
• 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
• Report Date (Section B): 04/13/2017

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2017
• Initial Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1