On (b)(6) 2019, a lexion insuflowport 5mm size trocar (p/n 4100-s) was utilized on a pt during a laparoscopic surgery.During this procedure, the pt developed a burn and blister on their skin near the incision site (abdomen) due to potential heat from the port.Lexion reported after the incident, there has been one other occurrence of potential overheating of the lexion insuflow port during surgery.Lab testing conducted by lexion for further inspection of the device has determined after extended periods of time, pt skin exposer to the external head of the port could produce minor skin irritation.(b)(4).
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