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

Model Number 9735602

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

The patient information will not be provided due to (b)(6) confidentiality laws.The initial reporter's name will not be provided due to (b)(6) confidentiality laws.System checkout is pending.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery.It was reported that the color around the lower right portion of the screen was abnormal.The system was restarted to resolve the issue.After the resolution, registration and navigation were being used, but suddenly the color on the screen faded, and although the navigation was recognized, it could not be confirmed on the screen at all.The cable was reconnected and the system was restarted multiple times, but the issue still persisted.The use of navigation was aborted.There was no patient harm and the procedure was not delayed.

Manufacturer Narrative

A manufacturer representative went to the site to service the system and replaced the computer which resolved the issue.A system checkout was then completed and showed the system was functioning as intended.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: the computer was returned to the manufacturer for analysis.Analysis found that the reported issue could be confirmed.The returned computer powered up in the test bench with static and discoloration on the display.Despite the anomalies on the screen, the computer was otherwise functional.Analysis found that the reported event was related to a computer component issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.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: FUSION COMPACT
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10742574
• MDR Text Key: 215384084
• Report Number: 1723170-2020-02817
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1