(b)(4).The facility has communicated that device is not available for investigation.P/n 544240 is not being manufactured currently, however, another part number from the same family was use for the verification of failure mode reported in the current manufacturing process and the samples were functionally inspected, and during the test issue reported "clips have moved away" was not observed in the current manufacturing process.The device history review could not be conducted since the lot number was not provided.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time, since the sample is not available is not possible to determine the source of the defect reported or to determine the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend related events.
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It was reported that after 8 months of surgery, the patient went to the emergency room for a cholangitis that required ct scan of the abdomen with mdc and subsequent admission to gastroenterology.Subsequent execution of ercp with removal of the calculations from the main biliary pathway and of two hem-o-lok clips closed, within the choleductus site, probably caused by retraction of the cystic duct and consequent migration of the same.The patient's condition was reported as fine.
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