Literature Review on the Incidence of Primary Stapler Malfunction

Abstract

Background. Surgical stapling devices are known for their reliability and convenience. A letter to health care professionals published by the US Food and Drug Administration in March 2019 highlighted the increasing number of adverse events associated with surgical staplers. Driven by a case of stapler malfunction during an elective laparoscopic sleeve gastrectomy, we performed a literature review to investigate the incidence of primary stapler malfunction. We also discuss the common types and an approach to its management. Methods. PubMed, MEDLINE, and EMBASE databases were searched for articles discussing surgical stapler malfunction. Twelve studies were selected that described the incidence and/or consequences of primary stapler malfunction. A narrative synthesis was performed. Results. From observational studies, the incidence ranged from 0.022% to 2.3%. A prospective survey reported that 86% of laparoscopic surgeons either had personal experience with or knew of surgeons who experienced stapler malfunction, implying a higher incidence. Underreporting has been an issue as manufacturers can get exemptions from public reporting. Significantly, higher malfunctions have been reported after exemptions were lifted. The most common types of stapler malfunction are stapler misfire and stapler locking. Major morbidity and mortality have been reported. Conclusion. Surgeons are increasingly reliant on technological innovations. Stapling failure occurs and it is imperative to be aware of this. Given the high volume of stapler use, a high percentage of surgeons are likely to encounter this problem in their career. It is important to have an approach to the prevention and management of this potentially catastrophic complication.

Keywords: biomedical engineering; colorectal surgery; gastric surgery.