Model Number 9735665 |
Device Problems
Display or Visual Feedback Problem (1184); Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: other relevant device(s) are: product id: 9735740, software version: (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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Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess).It was reported the monitor on the system was flickering and there was audio feedback and beeping during registration.This issue occurred intraoperatively and caused a less than one-hour surgical delay.There was no reported impact on patient outcome.Additional information was received stating a manufacturer representative was on site and unable to replicate the reported issued.
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Manufacturer Narrative
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A medtronic representative visited the site to test the equipment.Testing revealed that the system passed all tests and no parts were replaced.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 the cs was not in the case.The account called after they were having issues.The nurse stated it was acting up and didn't give any more details.
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Manufacturer Narrative
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H3: software logs have been received.However, analysis has not been completed at the time of filing.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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