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

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.

Manufacturer Narrative

H2: code corrections, see additional codes.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: the system computer (product id: 9736242, serial/lot#: (b)(6) ) sent for vendor analysis.The embedded display port (edp) was found to be faulty.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3.The system computer (product id: 9736242, serial/lot#:(b)(6) sent for vendor analysis.The system computer passed all functional testing in accordance to build instructions.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION FLEXENT
• Type of Device: EAR, 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 Key: 13180505
• MDR Text Key: 288034087
• Report Number: 1723170-2022-00019
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200723
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9736242
• Device Catalogue Number: 9736242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Date Manufacturer Received: 04/20/2022
• 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
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 59 KG