Catalog Number 8065751765 |
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 12/16/2020 |
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 vitrectomy probe did not perform the cutting function during surgery (aspiration condition unknown).The product was replaced and the procedure was completed.There was no patient harm.
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Manufacturer Narrative
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This event does not meet criteria as a reportable malfunction, based on information received following submission of the initial report.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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