Catalog Number 8065753041 |
Device Problem
Output below Specifications (3004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2021 |
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 physician reported that vitrectomy cutter of an ophthalmic operating console did not cut at 10000 cutting speed during a vitrectomy procedure.The surgery was completed by reducing to 8000 cutting speed.There was no patient harm.
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Manufacturer Narrative
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The company service representative, examined the system.And replicated the reported event.The nonconforming l5 valve of the pneumatics cable was replaced to resolve the issue.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to nonconforming l5 valve of the pneumatics cable.Data will continue to be monitored 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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