MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
|
Back to Search Results |
|
Model Number 9735669 |
Device Problems
Imprecision (1307); Data Problem (3196)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/11/2023 |
Event Type
malfunction
|
Event Description
|
Medtronic received information regarding a navigation device being used during a functional endoscopic sinus surgery (fess) procedure.It was reported that during a procedure on wednesday (b)(6), 2023 the site used a flat emitter and applied the strain relief tape for the non-invasive prenatal test (nipt).This scan was missing the top most portion of the patient¿s head.The site added points towards the ears from the beginning but since this patient was older, the best registration they could get was a large yellow circle.However, accuracy was on for most of the case (straight suction, 70 degree curved suction, quadcut straight 4.3mm blade, rad40 blade, 70 degree frontal balloon).Again, at the end some points in the maxillary sinus were checked.There was inaccuracies of 6.8mm from the medial maxillary wall and 4.7mm from the lateral wall.Both were showing further to the patient¿s right side.This was the same for the straight suction and 70 degree curved suction.All other anatomy was excellent.This was procedure two of three on that day.This occurred intraoperatively, and there was no surgical delay.There was no reported impact to patient outcome.
|
|
Manufacturer Narrative
|
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735736, software version: 2.0.1, udi#: h3, h6: a medtronic representative went to the site to test the equipment.Testing revealed that the system performed as intended, there were no failures found.The navigation system then passed the system checkout and was found to be fully functional.B01, c19, d14 are applicable.H3, h6: no logs have been returned to medtronic for analysis.B17, c20, d15 are applicable.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
|
H2/h6: the logs from the software were analyzed.There was insufficient information to determine the cause of the issue.Codes 01, c19, and d15 apply.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
|
|
|