MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MAIN CART 9735669 STEALTH S8 EM ENT; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735669

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Concomitant medical products: other relevant device(s) are: product id: 9735736, software version: 1.2.0.A manufacturer representative went to the site to test the equipment.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional with no issues.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 during a fess case, the surgeon had issues getting registration to pass.The surgeon tried with registration with both the nipt on the 3d model and turned off and also 3 point trace.The surgeon decided 3 point trace was better and moved forward with that.It was also noted that while tracing it took the surgeon a long time to pass minimum trace.The surgeon was adding a variety of points across the forehead, but it still wasn't filling up the registration bar as quick as it should have.There was a delay of less than 1 hour.No patient impact was correlated with this event.

Manufacturer Narrative

H3: the software investigation determined the software appears to be working as intended.The trace patterns from their attempted re gistrations looked pretty good, but it is possible that they were not collecting a diverse enough set of points to allow the software to hit the minimum trace threshold.Most of their trace patterns show a significant amount of retreading the same paths and tracing the same limited areas of the forehead as opposed to tracing more areas near the top of the skull.Additionally, for most of the t races the points tracing the patient's left temple are registered under the skin, which could be due to a bit of excessive pressure while tracing this area.Codes associated with the software: fdr 213, fdc 4315 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

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: MAIN CART 9735669 STEALTH S8 EM ENT
• 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: 9527002
• MDR Text Key: 187536096
• Report Number: 1723170-2019-06197
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169838918
• UDI-Public: 00643169838918
• 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: 02/21/2020

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 Model Number: 9735669
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 02/21/2020; 02/21/2020
• Supplement Dates FDA Received: 02/21/2020; 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1