Block h6: imdrf device code a0406 captures the reportable investigation finding of side car rx push back.Block h10: the returned trapezoid rx was analyzed, and a visual inspection found the side car rx was pushed back approximately 4 mm and device was leaking water from the handle.In the video submitted by the customer, it can be seen that the handle leaked.Based on all available information, the side car rx push back could have occurred due to excessive manipulation trying to open the basket or attempting to crush the stone.It is often seen that the side car is affected when excessive force is applied to the handle to open the basket.This was most likely also caused due to the amount of force applied on the thumb ring from the handle when trying to destroy the stone, and by this force applied, the working length tends to "retract" itself and therefore, pushing back the side car rx.Therefore, the conclusion code for the investigation finding of side car rx push back is adverse event related to procedure.However, the device was taken to x-ray to determine if there was something inside the handle that could be affecting the device and making this backflow.However, it was seen that inside the handle the spacer and the o ring are on position.Therefore, the most probable root cause for the reported event of handle leak is cause not established.
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