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Model Number 9735669 |
Device Problem
Imprecision (1307)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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No devices were returned to the manufacturer for analysis.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 there was an inaccuracy after registering the patient.They registered the patient with a 1.4 mm tolerance but when using the measure tool the inaccuracy looked close to 2-2.5 mm.They were inaccurate using different instruments including registration probe, and straight suction.There was a delay of less than 1 hour.No patient impact was correlated with this event.
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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: product id: 9735736, software version: 1.2.0 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.
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Event Description
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Additional information received: the representative stated the system is operating as intended and there is no need for system checkout.
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Manufacturer Narrative
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H2/h3: logs and archives were received and software analysis was done.The archive was reviewed.The image was per protocol.Registration was done with a 1.4mm accuracy.Traces were collected mostly on the forehead with a large yellow zone of accuracy.There were a few trace points under the skin on the soft skin area.It was suggested that trace points be collected around the head instead of only on the forehead.There was not enough evidence to know the root-cause of the inaccuracy.Codes 10, 213 and 4315 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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Search Alerts/Recalls
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