Catalog Number 8065830048 |
Device Problems
Fluid/Blood Leak (1250); Difficult to Open or Close (2921)
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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 when he inserted the instrumentation in and out of the trocar, the valve of the trocar did not close and water sometimes leaked during a procedure.The procedure was completed after replacing the product with another one.There was no harm to the patient.This one of two reports for this facility.
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Manufacturer Narrative
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A sample was not received.Therefore, the condition of the product could not be verified.No lot number was identified with this complaint.Therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site.And no lot information is available.Therefore, the root cause for the customer complaint issue cannot be determined.Investigations have been completed.And manufacturing process enhancements have been implemented in order to improve the performance of the valves.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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