Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 01/17/2014
Event Type
malfunction
Event Description
It was reported that during a lower anterior laparoscopic procedure two devices were leaking gas.The devices were replaced.There was no pt injury.
Manufacturer Narrative
Final device investigation found that only the component that attaches to the proximal end of the sleeve was returned in good visual condition.The remainder of the sleeve and the obturator were not returned.Upon eval it was found that the insufflation port and stopcock lever were securely fastened and had sufficient friction to prevent unintended movement.No pressure testing could be performed.The lot number was not provided so the device history record could not be reviewed.