Catalog Number 9735669 |
Device Problems
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Mechanical Problem (1384); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Unique device identifier (udi) is unavailable.Device manufacture date is unavailable.A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.
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Event Description
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A manufacturer representative reported that, while in a functional endoscopic sinus surgery (fess), the touchscreen of the navigation system lost functionality and then the system was unresponsive to prompts from the user.It was reported that the issue occurred during registration and that the mouse could move in the software but clicks did not respond.Restarting the navigation system resolved the reported issue.There was no reported impact on patient outcome.No additional information was provided.
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Manufacturer Narrative
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Additional information: device manufacture date and unique device identification (udi) provided.The logs for the navigation system were reviewed by medtronic personnel.However, the logs provided no additional insight into the probable cause of the anomaly.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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Other relevant device(s) are: product id: 9735736, serial/lot #: unknown, ubd: unknown, udi# unknown.The codes listed are applicable to the event upon further review.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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