The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported complaint.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated and without the device to analyze, a cause for the reported leak/splash associated with loss of fluid column after dilator removal cannot be determined.The unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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