Model Number TABLETOP |
Device Problems
Inability to Auto-Fill (1044); Gas/Air Leak (2946)
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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 during set up for a procedure an ophthalmic operating console was unable to run the auto gas filling without sufficient source of pressure and there was gas leak.The procedure set up was completed with a new product and they have replaced the tubing and this resolved the leak.There was no patient involvement.
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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 gas tubing 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 nonconforming gas tubing.Manufacturers 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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