Catalog Number 8065751908 |
Device Problems
Leak/Splash (1354); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/14/2018 |
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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An ophthalmologist reported that the trocars leak extremely and are unusable.Patient and procedure impact are unknown.The number of patients and devices involved are unknown.Additional information has been requested but not received to date.
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Manufacturer Narrative
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No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.No sample has been returned for evaluation for the complaint of leaky trocars; therefore, the condition of the product could not be verified.The exact root cause for this complaint is unknown, however, potential contributing factors related to the manufacturing, molding, and post cure processes of the valves has been identified.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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Event Description
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Additional information was received.The reporter informed that the trocars were exchanged and procedures were completed.The health condition of the patients involved was not affected.The reporter indicated that all of the trocars have been affected.The exact number and of patients and devices involved are unknown.
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Manufacturer Narrative
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Additional information provided in describe event or problem.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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