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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SURGN CART 9735665 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC SURGN CART 9735665 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735665
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 11/27/2019
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 9735859, serial/lot #: unknown. The ethernet bulkhead cable was returned to the manufacturer for analysis. Ethernet bulkhead was tested and found opens on pin 3 and 4. When manipulating the cable at the bad connection, the open was intermittent. One of the pins is visibly recessed on one side of the connector. The hardware investigation found that the reported event was related to a hardware issue. A manufacturer representative went to the site to test the equipment. It was reported that the bulkhead connector and router was replaced. The navigation system then passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used outside of procedure. It was reported that the navigation system was connecting very slowly to the network. The other systems at the site could connect relatively fast, but this one was taking upwards of 5-minutes to connect. The manufacturing representative bypassed the bulkhead and plugged directly into the network isolate but did not resolve the issue. The representative then plugged directly into the router and the system connected quickly, but tried to do it again and was slow. There was no patient present when this issue was identified. On 2019-dec-13 additional information received: the clinical specialist called to report that after the replacement everything was operating as intended. Yesterday, when the site tried to download the exams the exams were not able to transfer. They can query and see patients on pacs but the exams are not transferring. So far no error message has been reported only that the exams will not download and "get stuck" in receiving dicom. Technical services (ts) requested a picture of the screen when this is occurring. Ts also requested a timeout test for downloading the exams (the software should give an error after one minute. ) site is using the same ip address for all 3 stealth stations. Requested to follow up with it to see if they need the updated hw address from the new router.
 
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Brand NameSURGN CART 9735665 STEALTH S8 PREMIUM
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9601964
MDR Text Key184326324
Report Number1723170-2020-00174
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
Type of Report Initial
Report Date 01/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2018
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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