Catalog Number 8065751763 |
Device Problems
Failure to Power Up (1476); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2023 |
Event Type
malfunction
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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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Event Description
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A customer reported that during a surgery an ophthalmic operating console had issue with power and system stopped working in irrigation aspiration mode.Procedure details and patient impact were not reported.Additional information has been requested but none received till date.
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Manufacturer Narrative
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The company representative was unable to confirm nor replicate the reported event.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 non-conformance based review of the batch/lot/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 serial under investigation.The system was found to exhibit no functional issues in relation to the customer reported event.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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