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 02/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Brand name ; product id: 9736226, (lot: 1.3.2), product type: 2543-mnav - system.H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.Codes b17, c20, d15 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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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 during a case the registration trace points were off the patient and not anywhere near the patient's head.Also the system would collect points when the surgeon wasn't actively tracing and no instruments were in the field.The system was rebooted and the patient tracker was swapped and the navigation system and the issue persisted.Medtronic navigation was aborted.The event caused a surgical delay of less than one hour.Troubleshooting information was provided.The site swapped to a 3-point trace.They confirmed no metal interference.They edited the model and cropped to top of palate, changed threshold, retain head, auto refine.They moved patient tracker to side of head, was centered.It was suggested to change the registration probe and instrument tracker.
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Search Alerts/Recalls
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