A review of returned product from the customer was performed, initial actuation of the device was not possible.However, it was noted that with the device being inoperable due to bioburden, that the distal tip would protrude past the fep coating, if the finger rings were pushed forward.Soaking the tip of the device in alcohol for thirty minutes, with occasional attempts at actuation, caused multiple pieces of bioburden to expel from the distal tip (clevis mechanism).Once debris was cleared from the device it actuated, including under stress of bending the tip per ifu.It was also noted that with normal pressure the forceps would open as designed, but excessive pressure would again cause the distal tip to protrude past the fep coating.The complaint was confirmed.An exact root cause could not be determined with confidence, however the most likely cause of this issue was excess pressure applied to the finger rings while the device was inoperable due to bioburden build up.This caused the distal tip to be forced past the end of the fep coating due to mechanical leverage.The ifu for this device states "continuous flushing of the introducer sheath or guiding catheter with heparinized saline should be conducted while slowly withdrawing the biopsy forcep/specimen".This issue was most likely caused by an incident in the operating facility, therefore no corrective is needed.
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