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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problem No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 02/27/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. The suspect splitter has been received by the manufacture for evaluation. As reported, the returned splitter had no output when connected to a known good system. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database.
 
Event Description
A medtronic representative reported that while outside of procedure, when setting up for a case the site was unable to get video on the navigation system. During troubleshooting, representative reported that the surgeon monitor was not. The surgeon monitor was unplugged and plugged in a monitor for another navigation system and the other monitor was working. Then the staff cart monitor was not working. Video spliter was bypassed for the staff cart monitor and the monitor began to work. Video splitter was swapped from other navigation system and both surgeon and staff cart monitors were working. Surgeon monitor cable was plugged into non-working surgeon monitor and video appeared. The subsequent procedure was completed with one of the external monitors. There was no patient present at the time of the issue.
 
Manufacturer Narrative
The suspect cable has been received by the manufacturer for analysis. As returned, the cable was failing a continuity test. It was found that there were broken tabs on the fischer connector not allowing the outer shell to seat, properly aligning the pins to the key. After establishing the correct orientation, the cable passed a continuity test with no opens or shorts. However, due to the damaged connector, the fischer connector cannot be re-assembled correctly rendering the cable unusable. A new cable was shipped to the site. A medtronic representative went to the site to test the equipment. The navigation system then passed the system checkout and was found to be fully functional.
 
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Brand NameSTEALTHSTATION S7 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
sarah olhoft
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7363312
MDR Text Key103279351
Report Number1723170-2018-01250
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450944
UDI-Public00613994450944
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
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
Report Date 04/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2016
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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