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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 Intermittent Loss of Power (4016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/26/2018
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that the battery was found to be holding it¿s charge and the reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.No parts have been returned to the manufacturer for analysis.
 
Event Description
Medtronic received information regarding an imaging device being used for a functional endoscopic sinus surgery (fess) procedure.The issue was noted intra-perioperatively and had no impact on patient outcome.The delay in surgery was less than 1 hour.It was reported that while navigating, the system's blue light began to flash, and the system shut down on its own.The system was rebooted and the case resumed without issue.It was also noted that while in navigation admin, to open the self-test tool, the system started beeping and the power button began to flash while still connected to wall power.It was switched to another power outlet on site and the system resumed connection.It was using the same outlet as was in use in the clinical case.When the system recognized it was connected to power, the ups status showed normally.When disconnected from power, the uninterruptible power supply (ups) recognized it was on battery, but under "time until forced shutdown" showed "n/a on wall power".Self-test shows no connection to main cart touchscreen.
 
Manufacturer Narrative
The logs for the navigation system were reviewed by medtronic personnel.The logs showed that the software of the navigation system was functioning as designed and there were no indications of an anomaly.
 
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Brand Name
STEALTHSTATION S8 EM ENT SYSTEM
Type of Device
NEUROLOGICAL 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
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7799054
MDR Text Key117696135
Report Number1723170-2018-04134
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00643169838918
UDI-Public00643169838918
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 Physician
Type of Report Initial,Followup
Report Date 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9735669
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/26/2018
Initial Date FDA Received08/20/2018
Supplement Dates Manufacturer Received09/17/2018
Supplement Dates FDA Received09/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age49 YR
Patient Weight90
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