Block h6: imdrf device problem code a0406 captures the reportable investigation finding of side car rx push back.Imdrf device problem code a0501 captures the reportable investigation finding of handle cannula detached/separated.Block h10: the returned trapezoid rx was analyzed, and a visual inspection observed that the handle cannula was detached.Additionally, the side car rx was pushed back.Dimensional inspection observed the depth and length of the screws was within the allowed tolerances.The reported event was confirmed.The detachment of the handle cannula prevents the opening of the basket.This could have been generated if there was an excess of force applied when the handle was pulled.Also, the side car rx was found pushed back.Based on all the information available, manipulation of the device, technique used, or the patient's anatomical condition could have contributed to the event; therefore, the most probable root cause is adverse event related to procedure.
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