Design: A secondary analysis of the Manufacturer and User Facility Device Experience (MAUDE)-a voluntary reporting system by the Food and Drug Administration.

Setting: N/A

Patients or Participants: Between 2014-present, 414 AEs involving AirSeal devices were identified.

Interventions: N/A

Measurements and Main Results: 414 AEs were identified, estimating a complication rate of 0.01% for AirSeal devices (approx. 4 million devices manufactured over 10 years). Most AEs did not result in harm to patients (N=269, 66.0%). Material fragmentation/separation of AirSeal components was the device problem in 54.3% of reports. Most AEs involved portions of the trocar (N=282, 68.1%): the shaft (16.7%), tip (39.0%), and cap (33.7%). Patient complications included: retained foreign body (24.8%), air embolism (22.1%), subcutaneous emphysema (18.6%), and pneumothorax (9.7%). Of those with retained foreign body (N=37), the majority (N=24) related to the AirSeal cap. When the surgical service was known (N=307), AEs were most reported during urologic surgery (N=82, 26.7%) followed by gynecologic surgery (N=55, 17.9%). Distribution of complication type was different between gynecologic and non-gynecologic procedures (p=0.003). Gynecologic surgeries had less reports of air embolism, pneumothorax, and retained foreign objects, but more events of subcutaneous emphysema and tissue injury compared to non-gynecologic surgeries.

Conclusion: Over ten years, 414 AEs were reported involving AirSeal devices, representing an adverse event rate of 0.01%. Reassuringly, most reports had no direct patient impact. The most common device problem was material fragmentation/separation; the AirSeal cap was involved in most retained foreign bodies. Gynecologic surgeries had a distinct complication profile compared to other surgical services. While AirSeal offers improved maintenance of pneumoperitoneum in minimally invasive surgeries, surgeons must be aware of potential added surgical complications from this device.