Model Number TABLETOP |
Device Problems
Energy Output Problem (1431); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 an ophthalmic operating console exhibited had issue with foot pedal and upper bulb was out.The procedure details and patient impact were not reported.Additional information has been requested none received till date.
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Manufacturer Narrative
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The company representative was able to replicate the reported event.The footswitch and illuminator were replaced to resolve the issue.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 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 ¿laser foot pedal issue is attributed to nonconforming footswitch.The root cause of the reported ¿bulb issue¿ is attributed to nonconforming illuminator.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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