MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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Model Number 9736242 |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H3, h6: no hardware parts have been returned for analysis.B17, c20, d15 are applicable.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: (b)(4), software version: 2.1.0, ubd: , udi#: medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Medtronic received information regarding an imaging system being used during a functional endoscopic sinus surgery (fess) procedure.It was reported that tracking was intermittent during the third procedure of the day.This occurred intraoperatively, and there was a surgical delay of less than one hour.There was no reported impact to patient outcome.
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Manufacturer Narrative
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H2) correction: b5 corrected from previous mdr submitted, this event involves a navigation system and not an imaging system.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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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 tracking was intermittent during the third procedure of the day.This occurred intraoperatively, and there was a surgical delay of less than one hour.There was no reported impact to patient outcome.
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Event Description
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Additional information was received stating that the reported cause of the event was due to user error and not the system.The system wasn't up far enough and there was interference with the bed which caused the issue.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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