It was reported that there was an issue with fc700su - pas-port proximal anastomosis system.According to the complaint description, no anastomosis was achieved.Clamps were not formed properly, no anastomosis was achieved.The procedure was cancelled and a new device was used.An additional medical intervention was necessary.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).
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Investigation results: leading device/ reference code: (b)(4).Device name: pas-port proximal anastomosis system.Serial number: n/a.Batch number: 52632015.Manufacturing date: 24.09.2020.Product was available for investigation.Failure description: the device is in a used condition.Vigilance investigator carried out the pictorial documentation visually and microscopically.The sample is showing a rested part of the pe foil on the sealing area and the other part torn and loosened from the sealing area.As there is no hint for a material issue on the foil itself and due to tests performed during an earlier complaint (b)(4) which showed no deviation regarding the sealing, we therefore assume that there is no manufacturing issue.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.There are 5 similar complaints against the same lot number(s).Explanation and rationale: 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.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.A psc has been initiated.
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