It was reported that there was an issue with fc700su -pas-port proximal anastomosis system.According to the complaint description, no anastomosis was achieved.Surgery was stopped, suture continued by hand.An additional medical intervention was necessary.Additional information was not provided nor available was not available.The adverse event is filed under aag reference (b)(4).
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Investigation results: visual investigation: the device is in used condition.In similar cases like the present one, the investigation did not reveal any abnormalities on the pas-port device and the individual parts itself.No damages could be found which may explain the failure pattern.On the basis of the current information and knowledge, a clear conclusion cannot be drawn.Therefore, a product safety case (psc) has been initiated to evaluate the risk-benefit ratio, ref.(b)(4).The evaluation resulted in a field safety corrective action (fsca).A recall has been initiated.Due to the aforementioned, an in-depth investigation is waived.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that four similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.
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