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Model Number AAS00161-20 |
Device Problems
Radiofrequency Interference (RFI) (2314); Adverse Event Without Identified Device or Use Problem (2993); Patient Data Problem (3197); Program or Algorithm Execution Problem (4033)
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Patient Problem
No Code Available (3191)
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Event Date 02/21/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter during a procedure the system during registration is showing the green balls going all over the place.The account manager explained about possible interference.Tech support also explained that the incorrect patient plan may have been chosen, or the locatable guide is bad.The tech recommended to double check patient, board location, locatable guide replacement.After replacing the locatable guide, it did not solve the issue.The patient was under general anesthesia.The procedure was aborted and the patient was woken up.
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Manufacturer Narrative
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Evaluation summary: procedure recordings log analysis completed and no software malfunction found.Automatic registration analysis showed that all 4 automatic registrations were valid.First and second registration presented divergence in right upper lung(rul) and left bronchus, the fourth registration presented divergence in rul.Third registration was sufficient.In all four registrations the survey included areas outside of the 3d map (beyond the tree).Pst analysis showed patient sensor triplet(pst) movement during the first and second registration.Both pst movement during registration and survey outside of the 3d map can increase computed tomography(ct) scan to body divergence and affect registrations result.Ct to body divergence can be possibly caused by magnetic interference or due to pressure of the instruments during the survey.The review registration screen shows all the samples collected during survey.The processes of creating a valid registration can exclude some of these samples, so not all collected samples are included in the registration.The review registration feature shows the matching of all the collected samples to the 3d tree.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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