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

Catalog Number	9733449
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.The probe was not returned to the manufacturer for analysis because the customer canceled the request.No further action required.
Event or Problem Description
Medtronic received information regarding a navigation device during a functional endoscopic sinus surgery (fess) procedure.It was reported intraoperatively the site was not able to verify the straight suction probe.Other instruments were successful with verification.The site proceeded without using the straight suction probe.No surgical delay was reported.No impact on patient outcome.
Additional Manufacturer Narrative
Device lot number was provided by the site.Device manufacturing date was provided.

• 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: 7769898
• Report Number: 1723170-2018-03932
• Device Sequence Number: 13972205
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2018

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: 9733449
• Device Lot Number: 29543
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 141