Model Number TABLETOP |
Device Problem
Inability to Irrigate (1337)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2023 |
Event Type
malfunction
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Event Description
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A physician reported that before surgery an ophthalmic surgical console presented with infusion failure.Procedure details and patient harm was not reported.Additional information has been requested.Additional information was received the equipment displayed a system message which prevented the use of the equipment, although the reported infusion failure and completed with another device.No patient harm.
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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 product was not returned for 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.An internal investigation was opened on this issue but was later determined to be irrelevant.The complaint was determined to not be relevant to this investigation.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 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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Search Alerts/Recalls
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