Final device investigation found that the device was returned in good visual condition.Upon evaluation, the insufflation port and stopcock lever were securely fastened and had sufficient friction to prevent unintended movement.The device weal met the gap test criteria.The device sleeve was then pressure tested.The sleeve showed no signs of leaking when tested by itself, but did show signs of minor leaking when the obturator was inserted into the sleeve.No lot number was provided, so the device history record could not be reviewed.
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