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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 70 DEG CURVED SUCTION, AXIEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 70 DEG CURVED SUCTION, AXIEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9733450
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 (b)(4) privacy laws. Device lot number not available. Device manufacturing date is dependent on lot number, therefore, unavailable. 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. On 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 suction. All other instruments were accurate within 0. 5 millimeters. Suction 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
Correction to event date now provided. Correction to aware date now provided on initial mdr submitted: 11/15/2016. 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.
 
Manufacturer Narrative
Additional information: device lot number and manufacture date provided.
 
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Brand Name70 DEG CURVED SUCTION, AXIEM
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
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902187
MDR Report Key6175743
MDR Text Key62533114
Report Number1723170-2016-05764
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K050438
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,Followup
Report Date 05/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9733450
Device Lot Number16030143
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 Received05/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2016
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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