Catalog Number 8065830048 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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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A surgeon reported two of three valved trocars leaked during two procedures.The third trocar did not leak as it had the infusion cannula attached to it.The procedures were completed without product replacement and the samples were discarded.There was no harm to the patients.This is one of two reports for this surgeon.
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Manufacturer Narrative
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Additional information provided in h.6.And h.10.A sample was not received at the manufacturing site for evaluation for the report of there was leakage from the trocar ports; 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.Because a sample was not received at the manufacturing site and the device history record review indicated that the product was processed and released according to the product¿s acceptance criteria, 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 the manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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