|
Model Number 9735669 |
Device Problem
Human-Device Interface Problem (2949)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/20/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.It was reported that the site was having difficulty registering.Trace registration was performed multiple times.Collecting points was difficult and there was a delay between tracing on the patient and the points displaying on the 3d model.The best metric achieved with trace was 2.9.They attempted to add a touch point which increased accuracy metric but ended up removing the point.They proceeded to navigation with the inaccuracy accounted for.Troubleshooting was done when the complaint was reported.There was a christmas tree stand nearby the bed which may have contributed to metal interference, no known value available.The image provided showed the ct with the tip of the nose that appeared to be cut off as well as limited forehead space for tracing.Some artifact was present as well.The surface of skin on the 3d model appeared to have some pixels missing.Trace technique was on bony anatomy, traced up the nose and on the forehead, points collected mainly superficially with exception of on the nose and upper forehead because the anatomy was not present in ct.There was a delay of less than one hour and no impact to the patient.
|
|
Manufacturer Narrative
|
A medtronic representative went to the site to perform a system check out and they found that the system functioned as intended.No problems detected.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Additional information was received.It was reported that the amount of inaccuracy was unknown.
|
|
Manufacturer Narrative
|
Continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id: sfw kit 9735736, stealth s8 ent eu-sc, version: 1.2.0 h3,h6: the software was returned for analysis, and is currently being investigated.Fdm10, fdr3233, fdc11 are applicable to the software analysis.Fdm10, fdr213, fdc67 are applicable to the system checkout.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, h6: software logs were unable to provide additional insight about the issue.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.
|
|
Search Alerts/Recalls
|
|
|