AirSeal Access Port With Blunt Obturator and AirSeal Access Port With Optical Obturator

Product AirSeal Access Port With Blunt Obturator and AirSeal Access Port With Optical Obturator Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information. Audience Healthcare

Complaint review identified a prior manufacturing process update that may cause erroneous overpressure alerts under certain conditions, potentially leading to loss of pneumoperitoneum and treatment delays. Image was added to IFU to reinforce proper device tightening. No injuries or deaths have been reported.

RA-82267