Model Number V3.0 |
Device Problems
No Display/Image (1183); Operating System Becomes Nonfunctional (2996)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2022 |
Event Type
malfunction
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Event Description
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A physician reported that an ophthalmic operating console was locked with a dark screen.Procedure details and patient impact were not reported.Additional information has been requested none received till date.
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The company representative was able to replicate the reported event.The host was replaced to address the issue.The system was tested and found to meet product specifications.A non-conformance-based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The root cause of the reported event is attributed to a nonconforming host.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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