Catalog Number 8065751910 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 02/17/2018 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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An ophthalmic surgeon reported that during multiple procedures they experience leakage from the valved trocars.It was noted that at the beginning of the case it is like a dribble and after the instrument exchange it start like a spray.Additional information was requested.
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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 no 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 are presently being 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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