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

Catalog Number 9733449

Device Problems Imprecision (1307); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested.Replacement straight suction shipped to site (b)(6) 2016.No parts have been received by manufacturer for analysis.Part not received by manufacturer.

Event Description

A medtronic representative reported that, while in a functional endoscopic sinus surgery (fess), the surgeon alleged that their straight suction was inaccurate.The surgeon registered the patient with no issues, and checked accuracy with the registration probe and everything was fine.After verifying the straight suction with no issues, the surgeon deemed being a few millimeters off when touching known anatomical landmarks.All other instruments were accurate in the same locations.The surgeon was using the non-invasive patient tracker.The surgeon did not use the suction for the remainder of the procedure.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

• Brand Name: STRAIGHT SUCTION, AXIEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6147478
• MDR Text Key: 61610931
• Report Number: 1723170-2016-05669
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994378422
• UDI-Public: 00613994378422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9733449
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 54