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Model Number 9733533 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 used during a functional endoscopic sinus surgery (fess).It was reported that when trying to navigate on the screen, they had a low performance error.The exams only had 283 sliced and the spacing was not optimal but was 1x7.They had one patient tracker plugged in and three instrument trackers plugged in.One of the instrument trackers was non-sterile used to verify the instruments.The medtronic representative (rep) unplugged that tracker and the error went away.The rep unplugged different instrument trackers to make sure it was just the one.There was a delay of less than one hour and no impact to the patient.This was noted to be an out of box failure for the tracker.
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Manufacturer Narrative
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H2: see b5.H2, h3, h6: both returned trackers were found to be fully functional when connected to a known good system.Both were recognized, verified, and tracked without issue.No problem found.Codes 10, 213, and 67 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.
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Event Description
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Additional information was received.It was reported that there was for sure one tracker that wasn¿t working.The site thought there was another tracker that wasn't working.
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Manufacturer Narrative
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H3: software analysis completed and determined that there is insufficient information to determine whether a software anomaly contri buted to the reported behavior.H6: fdm b01, fdr 213, fdc 67 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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Search Alerts/Recalls
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