Catalog Number 8065750833 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/29/2020 |
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 physician reported that before a cataract surgery, the system froze.The surgery completed on the same day by restarting the system.There was no patient involvement.
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Manufacturer Narrative
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The system was examined and the reported event was replicated.The company representative replaced the central processing unit (cpu) and the cabling to resolve the issue.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause can be attributed to the cpu and cabling being nonconforming.However, it remains inconclusive whether only one or both of these parts contributed to the reported event, as the samples were not returned for evaluation.The manufacturer internal reference number is:
(b)(4).
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Search Alerts/Recalls
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