Supplement # 01 submitted to the fda on 26/may/2021.Device evaluation summary: the device was returned to the apollo device analysis laboratory on (b)(6) 2021.One tissue helix was returned with dried tissue present on the tip.There is blood present in the tubing.Prior to decontamination, the knob was turned, and the coil does not turn/rotate.The knob was pushed up and down and the coil did not retract.Under microscopic analysis, the outer sheath appears to be pulled away from the inner tubing.During rotation of the knob, the turning knob would stick and become intermittent on rotation.Due to the significant amount of dried tissue present on the distal end, visual observation of the tip could not be conducted.The complaint was verified as functional evaluation showed the rotation knob was difficult to turn.
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