MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S8 PREMIUM; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problem Environmental Compatibility Problem (2929)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

The system was serviced in the field and the system was shutting down unexpectedly.One the ups was replaced the pcoip host in the main cart was corrupted which caused the camera cart to not work.The ups and the main cart computer were replaced which resolved the issue.Concomitant medical products: other relevant device(s) are: product id: 9735787, serial/lot #: (b)(4), product id: 9735764, serial/lot #: unk.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the system shut down mid procedure.The site was unable to power system on the first few attempts.Blue light was not illuminated.The system finally booted up after holding blue power button.The site swapped to another system.A self test revealed 100% and normal behavior when unplugged from the wall.The issue could not be replicated after the case.The system was left on for multiple hours and the shutdown could not be replicated.There was no reported delay to the procedure.There was no reported impact to the patient.It was reported that after replacing the ups, the system was able to boot up, but the camera cart displayed pcoip error and splash screen, with no communication.The local representative (cs) double checked all connections in the main cart.The rep connected the main cart to the camera cart from another system, and it works as expected.The camera cart from the other system displayed the same error with this main cart, so the issue followed main cart.The suspected issue is with refurbished computer that was installed in a previous complaint.It was confirmed that this occurred while the system was plugged into a know functional outlet.It was noted that the cause was unknown but that the computer and ups were replaced.

Manufacturer Narrative

The uninterrupted power supply (ups) was returned to the manufacturer for analysis.The ups was tested for a period of one hundred and sixty eight hours and no issues were observed.The power switch functioned normally and all outputs measured normal voltage.No fault found.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The computer was returned and analyzed.Initial power on booted normally using a test solid state drive (ssd).Multiple power cycles were successful.The digital visual interface, high-definition multimedia interface and display port (dvi/hdmi/dp) outputs were all stable and the unit passed burning testing three times.No failures were found.Codes 10, 213 and 67 are applicable.Analysis provided the lot number of the computer which is 1734c00318.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: S8 PREMIUM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10190384
• MDR Text Key: 196561076
• Report Number: 1723170-2020-01749
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00763000272739
• UDI-Public: 00763000272739
• Combination Product (y/n): N
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 70 YR
• Patient Weight: 82