Surgical Stapler Adverse Events in the Veterans Health Administration

Abstract

In many operations, surgical staplers are utilized to ligate and divide blood vessels and other structures. Because staplers are often used to divide major blood vessels, adverse events may be associated with high morbidity and mortality. Previous research has identified a number of distinct failure modes. In the present study, 13 cases involving surgical staplers were identified in the Veterans Health Administration's adverse event database. Pulmonary operations represented the largest group, and outcomes were generally severe. A large number of the root causes involved environmental factors; user, equipment, and task factors were also identified. While surgical stapler use is generally safe, there are a number of steps that surgical teams could take to promote safe use and recovery from adverse events.

A novel approach to assess minimally invasive surgical device failure utilizing adverse event outcome severity and design complexity.

“…The number of recalls associated with the endoscopic staplers that correspond to the adverse event outcomes indicate that device failure shares responsibility, which is consistent with previous findings in the literature (Brown and Woo 2004, Kwazneski, Six et al 2012, Fuller, Paull et al 2014. Kwazneski et al state that both the number of recalls and the number of endoscopic stapling problems experienced by users suggests a redesign and remanufacture of the staplers could positively impact the safety profile of the devices (Kwazneski, Six et al 2012).…”

“…Specifically, the methods deployed in reaction to a failure may affect whether or not a malfunction causes an injury or death. Also, preventative techniques play an important role in the severity of outcomes of adverse events (Baker, Foote et al 2004, Fuller, Paull et al 2014, Mansour, El-Nashar et al 2014, which is emphasized further in the assessment of failure mode outcome severity in Chapter II.…”

“…presence of the clip was not included in the adverse event report). The device could also cause malformed staples due to a manufacturing defect, such as stapler misalignment (Fuller, Paull et al 2014). Typically, the event descriptions within the FDA MAUDE database reports are not specific enough to identify the root cause of failure mode that results in an adverse event outcome.…”

“…Administration (VHA) and mapped them to the following: 10 were environment issues (40%), seven were user issues (28%), five were task issues (20%), and three were equipment issues (12%) (Fuller, Paull et al 2014). Environmental issues include a lack of surgical team educational opportunities, overscheduling of cases, and lack of a standardized procedure to attain blood products in an emergency.…”

“…Poor visualization of the target tissue and friable tissue characteristics were cited to be task issues. Finally, equipment issues were defined as misalignment of the stapler and misfire (Fuller, Paull et al 2014). This brings attention to factors other than solely user and device related issues.…”