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Model Number 9733560 |
Device Problems
Communication or Transmission Problem (2896); Device Sensing Problem (2917)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/08/2020 |
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) procedure.It was reported that the site wasn't getting any communication with their axiem box.The site was able to reboot the system with no resolution.They then took off the site panel and reseated all cables into the axiem box.The number 7 was listed.In the tracking views the axiem box was listed as 2 red errors in the emitter details.Navigation was aborted.There was an unknown delay to the procedure.There was no reported impact to the procedure.Additional information was received.It was reported that the cause could not be determined, but the likely cause was due to old hardware.It was noted that there was no resolution other than new hardware which that site still has to purchase.
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Manufacturer Narrative
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H3: a medtronic representative went to the site to test the equipment.It was found that communication could not be established with axiem chain.Device replacement is pending.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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2020-jul-22 additional information received.The manufacturer representative went on site and confirmed axiem communication error was occurring due to a bad emitter.Em interface showed a single flt indicating the emitter was bad.
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Manufacturer Narrative
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Continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id: 9731203.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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