It was reported that during the case, the device without the obturator leaked gas at seal (losing surgical view) and became a problem when the stapler and tissue pouch were inserted, as it caused them to get "hung up" on each other.The device was not replaced.There was no pt injury.
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Final investigation found that the returned device was a model appcts22.The device was in good visual condition.Upon eval, a tear was found on the deep cone seal.Upon pressure testing, the device showed no signs of leaking when tested by itself, but showed signs of leaking when a test plug was inserted into the device.No lot number was provided, so the device history record could not be reviewed.As all devices are inspected prior to release, no conclusion could be made as to what may have caused the reported event.
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