Model Number TABLETOP |
Device Problem
Suction Problem (2170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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A customer reported that an ophthalmic operating console presented with vacuum issues.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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Additional information provided in sections d.9.H.3.H.6.And h.10.The company representative was able replicate the reported event.The fluidics module 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 the non-conforming fluidics module.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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Manufacturer Narrative
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The fluidics module was received for testing on this investigation.The visual inspection did not reveal any defects or abnormalities.The fluidics module was installed into a console and no non-conformities were observed during testing.Tests were performed and no non-conformities were observed during testing.Surgical test in phaco mode was performed before and after testing for 5 minutes and no non-conformities were observed.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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