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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 EM ENT SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 EM ENT SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9735669
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/24/2018
Event Type  malfunction  
Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.
 
Event Description
Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery (fess). It was reported that intra-operatively, after getting a passing registration, the site was not able to move forward and click the ¿verify accuracy¿ button even though it was highlighted blue. The site had passing registrations of 1. 9 and 2. 2 in previous registrations but couldn¿t proceed forward in the software with either registration. A manufacturer representative logged out and then logged back in, and all the previous registrations were red status and they couldn¿t select any. The representative tried to delete the patient and reload to perform another registration with a blank slate, but the site proceeded without navigation. Surgical time was extended by less than one hour and there was no reported patient impact.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional.
 
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Brand NameSTEALTHSTATION S8 EM ENT SYSTEM
Type of DeviceNEUROLOGICAL 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
amos jarrette
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208903200
MDR Report Key7621517
MDR Text Key111844108
Report Number1723170-2018-02898
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 07/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9735669
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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