Catalog Number 8065753057 |
Device Problems
Display or Visual Feedback Problem (1184); Inability to Irrigate (1337)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2022 |
Event Type
malfunction
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Event Description
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A physician reported that during a surgery an ophthalmic console exhibited irrigation failure in irrigation/aspiration mode and the balanced salt solution (bss) icon was grayed out.The surgery was completed with same pack after rebooting the system.There was no impact on the patient.
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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 service representative examined the system and was unable to confirm or replicate the reported event.The company service representative cleaned the camera part of the active irrigation module and checked the connection of a fluidics module cable.The system was confirmed to be functioning normally.The system was then tested and met all product specifications.A system 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 lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The system was found to exhibit no functional problems; therefore, the root cause of the reported event is inconclusive.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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