Model Number V3.0 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2021 |
Event Type
malfunction
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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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Event Description
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A customer reported the system turned off during the procedure.Additional information has been requested and received indicating the system turned off during a cataract extraction procedure.There was no system message displayed.Patient impact was not reported.
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Manufacturer Narrative
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The company service representative examined the system and was not able to confirm or replicate the reported event.The power cable was replaced as a preventative measure.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.Root cause the system was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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