Model Number TABLETOP |
Device Problem
Gas Output Problem (1266)
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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 healthcare professional reported that an ophthalmic system exhibited issues with dispensing gas.The scheduled procedure was vitrectomy.Patient impact have not been provided.
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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 regulator was replaced to address the issue.The system was tested and found to meet product specifications.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 non-conformance based review of the serial number was performed and a potential contributing factor to the reported complaint was identified.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The root cause of the reported event is attributed to nonconforming auto gas fill regulators.Actions taken 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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