MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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Model Number 9736242 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H3, h6: no hardware parts have been returned for analysis.B17, c20, d15 are applicable.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9736226, software version: 2.1.0, ubd: , udi#: h6: multiple fdd/annex a codes were reported.A0908 was coded for the inaccurate registration and navigation inaccuracy.A23 was coded for the yellow zone of accuracy being small and not green.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.
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Event Description
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Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the surgeon re-registered the patient 3 separate times and still did not get the desired accuracy.According to the manufacturer representative, the first registration accuracy was 2.4 millimeters (mm), but the yellow zone of accuracy was small and there were no green zone.Surgeon managed to the registration accuracy down to 1.9 mm but were still unhappy with the accuracy.The surgeon continued to move forward with surgery with the inaccuracy in mind.When navigating, the surgeon claimed that the navigation system was not navigating accurately.This occurred intraoperatively, and there was a surgical delay of less than one hour.There was no reported impact to patient outcome.
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Manufacturer Narrative
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H3) the system was serviced in the field and no hardware parts were replaced, the system performed as intended.Codes: b01, c19, d14 h2) please see section d4.And e.For additional information.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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