Catalog Number 8065751910 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Hemorrhage/Bleeding (1888)
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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 reported that at the beginning of the case it is like a dribble and after the instrument exchange it start like a spray.Leaking is occurring with 70% of the packs.Additional information has been requested.
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Manufacturer Narrative
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No sample has been returned for evaluation for the complaint of leaky trocars; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.Due to an observed increased trend for this event, an internal investigation was initiated to determine if corrective and preventative actions were necessary.A root cause for the increased complaint rate was found to be related to a manufacturing post assembly inspection practice.This complaint does not identify a reported lot and no sample was returned for evaluation so it cannot be determined if the complaint can be attributed to the post assembly inspection.The post assembly inspection has been discontinued and an effectiveness check has been established and will be monitored periodically.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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