Catalog Number 8065751765 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/04/2018 |
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.(b)(4).
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Event Description
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A physician reported the self closing valve trocar did not completely close causing overflow of the perfusion fluid and vitreous body during a procedure.The procedure was completed by using scleral plugs.There was no harm to the patient.No additional information is expected.
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Manufacturer Narrative
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No sample has been returned for evaluation for the report of leaking trocar; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are sixteen additional complaints associated with the lot for the reported issue.No sample was returned and the device history record review of the lot number provided indicated product was processed and released according to the product¿s acceptance criteria, therefore the root cause for the defect experienced by the customer cannot be determined.The exact root cause for this complaint is unknown.Investigations have been completed and manufacturing process enhancements have been implemented in order to improve the performance of the valves.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No additional action is required at this time.(b)(4).
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Search Alerts/Recalls
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