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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Laceration(s) (1946); Injury (2348); Blood Loss (2597)
Event Date 06/30/2017
Event Type  Injury  
Manufacturer Narrative
Per further engineering review, as the navigation system arms are packaged under tension, if the velcro is removed before the monitor or camera are installed, then the arms will open with considerable force. Current controls include a velcro strap and warnings in the instructions for use (ifu) to warn the user to not remove the velcro without attaching the arm or camera. The design of the arms is similar to previous navigation systems, so mitigations/controls were deemed adequate for the current navigation system. The root cause of the injury was that the velcro was removed prematurely, with no counterbalance on the end of the arm. The instructions for use (ifu) that accompanies the device contains the following warnings, "warning: the arm will extend fully and without warning without the hook-and-loop strap in place and tight. Impact injuries to the face, head, and hands may occur. Do not remove the arm from the shipping box if the hook-and-loop strap is not in place around the arm. Do not remove the hook-and-loop strap around the arm. ".
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The representative was unable to replicate the reported issue. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional.
 
Manufacturer Narrative
Correction: the medtronic representative received 12 sutures about an inch in length and antibiotics, while in the emergency department. Additional information: training provided to the medtronic representative was reviewed and confirmed that the rep was properly trained to navigation system on-site installation instructions prior to this event. Added additional patient code.
 
Manufacturer Narrative
No evaluation has been performed as the root cause of the anomaly was found to be a use error. The medtronic representative did not follow the instructions for use (ifu) when installing the navigation system.
 
Event Description
A medtronic representative reported that, while uncrating a navigation system, the monitor arm of the system released and struck the representative in the nose. It was reported that the screw on top of the metal bracket stuck the representative on the nostril. The representative went to the er for stitches. It was reported that the representative removed the velcro strap on the arm, which is to be tightened until installed. It was reported that the representative did not follow the installation instruction. No additional information was provided.
 
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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
oksana ditolla
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902082
MDR Report Key6750156
MDR Text Key102397546
Report Number1723170-2017-03113
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup,Followup
Report Date 10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2017
Is this an Adverse Event Report? Yes
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 Received09/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/28/2017 Patient Sequence Number: 1
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