It was reported that there was an issue with fc700su - pas-port proximal anastomosis system.According to the complaint description, during rotating the knob of the delivery system to fired the staple to aorta, some kind of a chip such as the material of pps came off the device.As the chip might come off the knob of the device and fell on the distal end of the housing of delivery device, the chip was easy to see and retrieved from the point.The anastomosis itself with use of the pps was completed without any problem.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under (b)(4).
|
Investigation results: visual investigation: the particles have been analysed visually.The particles were provided inside of liquid.A clear assignment of the particles is not possible, especially without the pasport device itself.It is possible that these are plastic particles from inside the device, but how and why the occurred cannot be finally determined.Based on the provided information and after the investigation, a clear conclusion cannot be drawn.There is no indication for a manufacturing or material failure according to the dhr files.The separated particle cannot be assigned, especially without the pasport device itself.On the basis of the statistical analysis and market surveillance, this is an individual case.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 no 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.Based upon the investigations results a capa is not necessary.
|