MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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Model Number 9736242 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2024 |
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: 9 736226, serial/lot #: 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 a navigation system being used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the surgeon claimed there was an inaccuracy during surgery.When the surgeon was navigating the bone, the navigation screen was showing that he was in the soft tissue instead.The scan was obtained in february, but the surgery was in march.The issue occurred when verifying instruments.There was delay of less than one hour and no reported impact to patient outcome.
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Manufacturer Narrative
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H3, h6) the system was serviced in the field and the system performed as intended, no faults were found.Codes b01, c19, and d14 are now applicable.H2) a1-a4) patient information was unavailable from the site.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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Search Alerts/Recalls
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