One used reload was received on 3/27/2019.It was examined and there was evidence of staple travel and several indications that staples were deployed.The reload anvil opened when the top lever was raised.The anvil was examined under a microscope and staple travel was confirmed.During manufacturing, the staple cartridge is confirmed to contain all staples at three different checkpoints.Based on the returned device investigation, it was determined that there was no device malfunction.The investigation findings are indicative of tissue that is too thick or the device is not clamped appropriately on the tissue.
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The surgeon reported that, during a laparoscopic appendectomy, the stapler cut and appeared to fire but no staples were deployed.The doctor did not visibly see any staples in the tissue.The stapler appeared to fire normally and there were no atypical noises.The cecum was open on the far side and then "zippered" open all the way.He placed an endoloop on the stump of the cecum.There was nothing out of the ordinary in the appendix pathology, which indicated appendicitis.The patient experienced no adverse effects.The surgeon was unable to provide patient gender when requested.
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