MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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Model Number 9735669 |
Device Problems
Mechanical Problem (1384); Application Program Problem (2880)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735825ent, h3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 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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Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery (fess) procedure.It was reported that during surgery, the system suddenly showed a breakout box faulted message while the surgeon was navigating.The system was rebooted and the breakout box was unplugged and re-plugged in but the issue did not resolve.The surgery was continued without navigation. additional information was received, it was reported that technical services (ts) walked the representative (rep) through diagnostic tool and received the following 'status for em: bob faulted; diag for em: bob rom'.It was noted that the system was recently installed.
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Event Description
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Additional information was received.It was reported that there was no reported delay to the procedure due to this issue.There was no reported impact on patient outcome.
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Manufacturer Narrative
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H2: additional information added to b5.H3: a medtronic representative went to the site to test the equipment.Testing revealed that the breakout box was showing a fault.Once the new breakout box was installed, the issue resolved.The navigation system then passed the system checkout and was found to be fully functional.H6: fdm b01, fdr c02, fdc d02 are applicable 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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Manufacturer Narrative
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D9, h2, h3: the return of 9735825r provided the lot number 1600605220.The hardware was returned and analysis was performed.The em interface faulted immediately when plugged into the lat station.All leds were illuminated including the amber fault led.The ports were not functional and localizer status displayed faulted.The em interface was unable to connect to the emtest.Codes b01, c02, d02 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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