MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. MALLEABLE SUCTION MEDIUM, ANGLE TIP; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number 9735017

Device Problems Suction Problem (2170); Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2015

Event Type  malfunction  

Event Description

A medtronic representative reported that during a functional endoscopic sinus surgery (fess) the malleable suction instrument stopped tracking, while other instruments continued to track.The malleable suction was replaced and the new instrument tracked as expected.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Patient weight not available from the site.Replacement device shipped to site (b)(4) 2015 for issue resolution.No parts have been received by the manufacturer for analysis.

Manufacturer Narrative

Correction: device is a one time use disposable instrument, not a reusable device.

• Brand Name: MALLEABLE SUCTION MEDIUM, ANGLE TIP
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: catherine eaton ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902092
• MDR Report Key: 4519465
• MDR Text Key: 5530643
• Report Number: 1723170-2015-00173
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/22/2015

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
• Device Operator: Physician
• Device Catalogue Number: 9735017
• Device Lot Number: 140609
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 02/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR