Catalog Number 8065797105 |
Device Problems
Gas Output Problem (1266); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2022 |
Event Type
malfunction
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Event Description
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A customer reported that perfluoropropane gas bubble in eye reduced in size prematurely in the patient eye.Procedure was completed and patient harm was not reported.Additional information has been received indicating that the event occurred during surgery but not noted until post operative (post-op).The gas fill was noted to be low at post-op and perfluoropropane was not dispensed.
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Manufacturer Narrative
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This report originally filed under mfg report num 1610287-2022-00027.All future reports will be submitted under mfg report num reflected in this report.The c3f8 tank was not returned for evaluation.A review of the batch production record could not be performed because the lot number was not reported.The expiration date could not be determined.A review of the complaint records could not be performed because the lot number was not provided.A review of confirmed complaints for leaking cylinders of this type or for c3f8 not lasting as long as expected.Both were for cylinders that leaked at the valve to cylinder connection.The root cause of the reported event cannot be determined.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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