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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SYSTEM FUSION EM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number FUSION
Device Problem Imprecision (1307)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2016
Event Type  malfunction  
Manufacturer Narrative
The site declined to provide patient information, per canadian privacy laws. A medtronic representative, following-up at the site, reported both suctions verified successfully without manipulation, and within a few seconds, however, were inaccurate by approximately 4 millimeters s/i and 2 millimeters a/p. All other instruments, including curved suctions from another tray, were accurate. The surgeon stopped using these instruments, and continued the procedure with minimal delay and no patient impact. 11/15/2016-a medtronic representative performed a navigation system check-out, software and hardware areas passed. Instruments test failed. Curved suctions were several millimeters inaccurate. Items will need to be replaced. Recommended instrument replacement. Issue resolved. System performed as intended. It was reported that the suctions that were inaccurate were accidentally sent through the incorrect sterilization process by the site, because of this error, the suctions, became damaged. The site has been made aware and will replace the suctions. Return requested for curved suction 70 and curved suction 90 on 11/17/2016. No parts have been received by manufacturer for analysis. No further issues have been reported.
 
Event Description
A medtronic representative reported that, while in a functional endoscopic sinus surgery (fess), the surgeon alleged an inaccuracy occurred. The surgeon alleged a 4 millimeter inaccuracy with the curved 70 degree and 90 degree suctions. All other instruments were accurate within 0. 5 mm. Both suctions verified with no issue, however, the surgeon deemed being inaccurate using them. The doctor stopped using these instruments and continued 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.
 
Manufacturer Narrative
Additional information: although a specific cause of the reported incident was unconfirmed as the part was not received to the manufacturer, an investigation into returned parts with similar reported malfunctions was completed via capa investigations.
 
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Brand NameSYSTEM FUSION EM
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
oksana ditolla
826 coal creek circle
louisville, CO 80027-9710
7208902187
MDR Report Key6168678
MDR Text Key62234461
Report Number1723170-2016-05690
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K001284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 04/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFUSION
Device Catalogue Number9733560
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 Received03/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/24/2016
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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