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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9736242
Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2021
Event Type  malfunction  
Event Description
Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess) procedure. After loading the exam via disc, registering, and advancing to the verify registration page, the 3d model appeared to be pixelated and the system reboot to an error screen. An attempt was made to register again, but the issue persisted. A hard reboot was performed and the registration as no longer present. Registration was performed again and the procedure was continued without issue. The reported issue resulted in an approximate procedure delay of 7 - 8 minutes. The probable cause was reported as hard drive corruption. There was no impact on patient outcome.
 
Manufacturer Narrative
Concomitant medical products: product id: 9736242, serial/lot #: (b)(4), ubd: unknown, udi#: unknown. Product id: 9736242, serial/lot #: (b)(4), ubd: unknown, udi#: unknown. Product id: 9736242, serial/lot #: (b)(4), ubd: unknown, udi#: unknown. Product id: 9736226, software version #: 1. 3. 2 product id: 9736242, serial/lot #: (b)(4), ubd: unknown, udi#: unknown. Product id: 9736242, serial/lot #: (b)(4), ubd: unknown, udi#: unknown. A medtronic representative visited the site to evaluate the equipment. Hardware parts were replaced. Codes b01, c13, and d02 are applicable. The returned computer was analyzed. The rep tried to boot system and it wasn't detecting a boot device. Opened the back ssd panel and discovered the thumb screw on the ssd sled was not tightened, therefore the sled was moving around and the drive was not plugged in. Plugged drive in, tightened thumb screw and the system boots as expected. Codes b01, c07, and d02 are applicable. Logs and archives were analyzed. It was found that this is a known software issue. Codes b01, c10, and d02 are applicable. The returned computer was analyzed. The rep found the screw on the ssd tray was not tightened and the ssd was loose and not seated in the ssd connector causing the computer to bootup in the bios boot screen. When the ssd was seated and tightened down the computers stealthstation self-test reported that the stealthstation has not been configured yet. System functioned normally without failure. Codes b01, c07, and d02 are applicable. The returned computer was analyzed. The rep tried to boot system and it wasn't detecting a boot device. Opened the back ssd panel and discovered the thumb screw on the ssd sled was not tightened, therefore the sled was moving around and the drive was not plugged in. Plugged drive in, tightened thumb screw and the system boots as expected. Codes b01, c07, and d02 are applicable. The returned computer was analyzed, and no failures were found. Codes b01, c19, and d14 are applicable. The returned computer was analyzed, and no failures were found. Codes b01, c19, and d14 are applicable. It was reported that the replacement aio would not boot, and did not prompt for bios password. Reboots did not resolve. The ssd was not being recognized. It was noted that it was possibly dislodged, but without an electrical safety kit, the local representative ((ent) could not perform further troubleshooting. It was reported that there were three out of box failures (oobf). The first oobf was able to boot up, bios text, but was unable to boot into the application. The cc could hear the ssd rattle. The second oobf was unable to boot up, no bios text, and had a back lighted screen, blue power button, an the cc could hear ssd rattle. The third oobf, the local representative (cc) swapped outlets and the issue did not resolve. The aio booted to a black screen with the blue power button illuminated, the cc could hear the system attempting to boot, but the screen remained black. The cc could also hear the ssd rattling around. It was reported that the aio loaded and booted up. 1. 3. 2 and ent license installed. The local representative (rep) exported all patients from original ssd (did not use data migration) used usb export function. All exams were transferred over. The system rebooted. The blue light illuminated with a black screen. The rep could hear fans, blue light. After 20 reboots and outlet swap. The rep was unable to boot out of the black screen. The ent rep still had the original system reported for this case. The original reported issue was a self reboot mid-case. This could not be replicated and the decision was made that the system needed to be replaced since this was mid-surgery. The surgeon would not like to proceed forward with utilizing the original aio. The rep attempted ctrl+alt+delete, but there was no grub menu. It was reported that after installing, the cc received (only one instead of two) that there were different colored pixels flashing around any screen with black backgrounds and in stealth admin. He was trying to display on an external monitor and see if the same result occurred. He saw the pixels as soon as he turned the system on, before and after any software was installed. It was reported that when video was exported to an external monitor, the pixelation did not appear on that monitor. When a scope video was input into the system, there was pixelation on that display. The issue appeared to be with the monitor display. It was reported that the 5th aio resolved the issue. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTEALTHSTATION FLEXENT
Type of DeviceEAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13180505
MDR Text Key288034087
Report Number1723170-2022-00019
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200723
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 05/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9736242
Device Catalogue Number9736242
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2021
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? Yes
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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