Catalog Number 8065753041 |
Device Problem
Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2024 |
Event Type
malfunction
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Event Description
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A health care professional reported that the ophthalmic operating console vitrectomy cutter not working during retinal detachment surgery.The surgery was completed on the same day with no patient harm.
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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 health care professional reported that the ophthalmic operating console had no vacuum during vitrectomy surgery.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
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Search Alerts/Recalls
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