MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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Model Number 9736242 |
Device Problem
Imprecision (1307)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: section d information references the main component of the system.Other relevant device(s) are: product id: 9736226, software version: 2.0.1 h3, h6: no products have been received by the manufacturer for 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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Event Description
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Medtronic received information regarding a navigation system during a functional endoscopic sinus surgery (fess) procedure.It was reported that the site experienced an alleged inaccuracy.It was reported that there was an inaccuracy of about 6.5 mm anterior when navigating in the back of the sinuses with all instruments.This alleged inaccuracy decreased as the instruments got closer to the front of the face, and the navigation was accurate on the front of the face.The medtronic representative (rep) did note that the site does reuse both instruments and patient trackers.The surgeon didn't want to reregister and continued taking into account the perceived inaccuracy.The instruments used were a quadcut, rad 40, straight suction, and 70° suction.There was less than an hour delay in surgery.There was no impact on patient outcome.
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Manufacturer Narrative
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H3: a software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.Codes b01, c19, d15 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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Search Alerts/Recalls
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