Model Number TABLETOP |
Device Problems
Self-Activation or Keying (1557); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2022 |
Event Type
malfunction
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Event Description
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A physician reported that ophthalmic console having issues with cutters sputtering and footswitch not working to change surgical modes.The surgery was completed by replacing the ophthalmic console with other one.The details about patient harm was not reported.
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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 confirmed and replicated the reported event.The pneumatics module and the footswitch were both replaced to address the issue.The system was tested and found to meet product specifications.A non-conformance-based review of the batch/lot/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 lot/batch/serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.The complaint was determined to be relevant to this investigation.This complaint details a previous occurrence of the same event a week before this reported event.The root cause of the reported event is attributed to the nonconforming pneumatics module and footswitch.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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