MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9733560XOM

Device Problem Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable.No testing was performed on the system because the site did not elect for a system checkout to be completed.No parts have been returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess).It was reported that the ear, nose & throat (ent) software had moved back a few times to a different task when verifying the straight and curved suctions in the non-invasive patient tracker (nipt) divot.The surgeon stated that the instruments were in the divot, not hitting the arrows on the tracker.This issue occurred intraoperatively.There was no impact on patient outcome.It was later reported that the issue has not reoccurred since this event.

Manufacturer Narrative

Device evaluation: a software analysis was completed but it was unable to determine probable cause without further information since the behavior cannot be replicated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION¿ ENT NAVIGATION SYSTEM
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8136341
• MDR Text Key: 129468914
• Report Number: 1723170-2018-06085
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

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: Health Professional
• Device Model Number: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2013
• 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