Catalog Number 8065750290 |
Device Problem
Energy Output Problem (1431)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/23/2023 |
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 nurse reported that before vitrectomy surgery lamp in the table top illuminator of an opthalmic operating console presented low brightness.Patient impact details were not reported.Additional information has been requested none received till date.
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Manufacturer Narrative
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Service history was reviewed for the system.No service record relevant to the complaint reported event was found.All manufacturers surgical systems are verified to meet specifications after installation and customer initiated servicing in accordance with the applicable procedure.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.No similar complaints were reported for the product lot/batch/serial under investigation.Based on the information obtained, the root cause of the reported event is inconclusive.Manufacturers 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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Manufacturer Narrative
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The company representative was able to replicate the reported event.The lamp was subsequently replaced and then returned for testing on this investigation.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 lamp was received for testing on this investigation.A visual assessment of the returned sample revealed discoloration to the wire.The returned sample was installed into a console and tested.The illumination output was low.The reported event was replicated.The root cause of the reported event is attributed to nonconforming lamp.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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