MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number 9735669 |
Device Problems
Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993); 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 03/08/2024 |
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: 9735736, software version #: 1.2.0 h3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.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 used during an unknown procedure.It was reported that the surgeon could not proceed past registration and onto navigation.The surgeon completed and passed trace registration, but then could not click the button (via touch and mouse) to proceed to navigation.The button was unresponsive.They rebooted the system and trace registered the patient multiple times before aborting use of the system.Delay information was unknown.There was no reported impact to the patient.Additional information was received.It was reported that the procedure was a functional endoscopic sinus surgery (fess).There was a reported delay to the procedure of 30 minutes.
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Manufacturer Narrative
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H2-3) the software analysis concluded that the logs did not capture any corefile, no database issues, no rabbitmq error, no segfault, no low performance and no graphics processing unit (gpu) crash observed on the date of issue.The information provided was insufficient to determine whether a software anomaly contributed to the reported behavior.Codes: b01, c19, d15 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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