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Instrument Failures for the AirSeal device: a Food and Drug Administration MAUDE Database Study

Objective: This study aims to analyze instances of AirSeal device failures reported in the Food and Drug Administration's MAUDE (Manufacturer and User Facility Device) database, focusing on identifying trends in failure types and locations.

Summary Background Data: The AirSeal device has revolutionized minimally invasive surgery by providing stable pneumoperitoneum and optimal visualization. However, concerns about its reliability and safety have surfaced.

Methods: Retrospective analysis of the MAUDE database. A search for ‘AirSeal’ device-related events from 2014 to 2023. A total of 411 events resulting in injury, death, or other complications were identified, and data were extracted from these reports. Data extraction included report number, event date, event type, manufacturer, patient problem, and number of events. It should be noted that detailed information such as the specific organs involved or the exact surgical procedures were not available in the MAUDE database reports.

Results: Over the 9-year period, 411 AirSeal device-related events were reported in MAUDE. The predominant failure mechanisms included device breakage 266 (64.7%), defective failures 16 (3.9%), flow failures 13 (3.2%), leak failures 8 (1.9%), patient-device interaction issues 5 (1.2%), and pressure-related failures 4 (1.0%). Among the reports, incidents related to the valveless-trocar included 261 (63.5%), whereas the insufflator was implicated in 150 reports (36.5%). The most common event reported involving the patient was embolism listed in 35 cases. There is also an increase in the number of cases reported annually.

Conclusion: Further research is warranted to understand the root cause of device failure and implement targeted interventions aimed at mitigating any risks associated with the AirSeal device. Ultimately, collective efforts are directed toward upholding the highest standards of patient safety in this era of minimally invasive surgery.

Laith Baqain (Medical Student),1 Sanad Haddad (Medical Student),1 Ronny Baqain (Medical Student),2 Kristene Myklak,3 Ryan W. Dobbs,4 David I. Lee,3 Mohammed Shahait,5

  1. University of Jordan, Jordan
  2. University of Manchester, United Kingdom
  3. Department of Urology, University of California at Irvine, Irvine, CA, USA
  4. Department of Urology, Cook County Health & Hospitals System, Chicago, USA
  5. Department of Surgery, Clemenceau Medical Center, Dubai, UAE
Source: Baqain L., Haddad S., Baqain R. et al. Instrument Failures for the AirSeal device: a Food and Drug Administration MAUDE Database Study. Current Problems in Surgery. 2024. 101629, ISSN 0011-3840, https://doi.org/10.1016/j.cpsurg.2024.101629.