MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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Model Number 9736242 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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No devices were returned for analysis.Device manufacturing date is unavailable.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 device.It was reported that the system was unresponsive after log in.This occurred after they received internal error 64.There was a 5 min delay to the procedure and no impact on patient outcome.The manufacturing representative (rep) was on site troubleshooting.The reported issue happened in operating room (or) 9.In or 9, the repeated the 3 hour test with the navigation system connected to the power outlet labeled davinci 1.Nothing else was plugged into the outlet.He was unable to replicate the issue.On 5/13, a surgeon had a 5 hour fess case during which he plugged the navigation system into the outlet in or 9 labeled davinci 2.No other equipment was plugged into the outlet.The system performed as intended.Moving forward, the site will plug the navigation system into the davinci 2 outlet for surgery and will plug all other equipment into the davinci 1 outlet.
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Manufacturer Narrative
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H3: a software analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.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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