A product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.We could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.However, a device failure was not reported, only post procedure complications.The instructions for use include the following potential complications: "potential complications associated with ercp include, but are not limited to: pancreatitis, cholangitis, aspiration, perforation, hemorrhage, infection, sepsis, allergic reaction to contrast or medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest." prior to distribution, all d.A.S.H.Dometip double lumen sphincterotomes are subjected to a visual inspection and functional test to ensure device integrity.A review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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