MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
|
Back to Search Results |
|
Model Number 9736242 |
Device Problems
Display or Visual Feedback Problem (1184); Environmental Compatibility Problem (2929); Application Program Freezes, Becomes Nonfunctional (4031)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/28/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Concomitant medical products: product id: 9736226, (sfw kit 9 stealth flex ent).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.
|
|
Event Description
|
Medtronic received information regarding a navigation device.It was reported that there was an unexpected shutdown during a case.The screen when black they got the error 64 and had to reboot the system.There was no impact to the patient outcome.
|
|
Manufacturer Narrative
|
H3, h6: a medtronic representative went to the site to perform a system check out and they found the system functioned as intended.B01, c19, d14 are applicable to the system checkout.The logs and archives were returned for software analysis.Review of the logs found segfault in the libnvidia.A crash was observed while invoking17 mre::details::defaultshaderstoragebufferobject from the function initialize() in the defaultshaderstoragebufferobject.Cpp.B01, c10, d02 are applicable to the software analysis.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
|
|
|