MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 70 DEG CURVED SUCTION, AXIEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733450
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not yet returned to manufacturer.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess).The issue occurred intraoperatively while verifying instruments and delayed the surgery by less than one hour.It was reported that there was difficulty registering the 70-degree suction.The suction did eventually get registered and it was the only instrument showing inaccurate.The surgery was completed with navigation and there was no impact on patient outcome.
Additional Manufacturer Narrative
The curved suction was returned to the manufacturer for analysis.Analysis found that the returned curved suction was not able to verify when attached to a known good tracker returning a divot error of 3.6 mm to 3.8 mm.Analysis found that the reported event was related to a mechanical issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 70 DEG CURVED 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: 7891845
• Report Number: 1723170-2018-04857
• Device Sequence Number: 19424486
• Product Code: HAW
• UDI-Device Identifier: 00763000053390
• UDI-Public: 00763000053390
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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 Catalogue Number: 9733450
• Device Lot Number: 26337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 35