MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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Model Number 9736242 |
Device Problems
Communication or Transmission Problem (2896); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2021 |
Event Type
malfunction
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Event Description
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Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess).It was reported that the system suddenly froze and did not show the health care professional where they were.Nothing could be changed on the screen.The site performed a hard reset.There was less than an hour delay in the case.No impact on patient outcome.
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Manufacturer Narrative
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The manufacturer representative went to the site to test the navigation system.No hardware parts were replaced.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information was added to the event description.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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Additional information was received stating that after the system was hard reset the procedure was able to be completed.
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Manufacturer Narrative
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H6: logs were received and software analysis was completed.The logs did not capture any core files or segfaults.An improper shutdown was captured.It was noted that this might have been because of the hard reset that was performed.However, the logs provided insufficient information to determine the root cause of the reported behavior.Codes b01, c19 and d15 are applicable to this 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.
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Manufacturer Narrative
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Correction: d10 updated.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735225r, serial/lot : 1.3.0, ubd: , udi: (b)(4) h3: the system logs were received, analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.H6: codes b01, c19, and d14 still remain as they pertain 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.
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