Catalog Number 8065751904 |
Device Problem
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 04/18/2018 |
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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A physician reported that several doctors have experienced issues with trocars that are not watertight.The procedures were completed same day without medical or surgical intervention.
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Manufacturer Narrative
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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 four additional complaints associated with the lot for the reported issue.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.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.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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