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.

Continuously sutured versus linear-stapled anastomosis in robot-assisted hybrid Ivor Lewis esophageal surgery following neoadjuvant chemoradiotherapy: a single-center cohort study

“…Stapling has been shown to facilitate and accelerate the creation of the anastomosis in different surgeries [ 10 ]. However, stapling might also prove to be technically challenging and associated complications have been reported [ 11 , 12 ].…”

Comparative Finite Element (FE) Analysis of the Mechanical Behavior in an Innovative Nitinol Staple for Arthrodesis in Distal Interphalangeal Joint

“…The use of nitinol staples allows applying compressive force able to maintain the alignment of bony fragments, thanks to its intrinsic super elastic and shape memory properties. [31][32][33] Obviously, the higher contact forces decrease micro motion facilitating a proper bone healing and reduce the rate of fixation failures. 34 Joint adjustments or bone resorption happen on the arthrodesis site and an appropriate contact force succeeds to furnish an adequate compression to guarantee the healing process.…”

Bioadhesive Technology Platforms

“…To expedite wound closure, surgical staplers were adopted throughout the late 1900s, offering rapid application and facilitating less invasive procedures . Nonetheless, staplers also have their share of disadvantages, including a high incidence of device malfunctions and adverse effects such as leakages and tissue tearing. , Moreover, the pointwise, tissue-penetrative modality of both sutures and staples is intrinsically damaging to tissues and can result in poor healing.…”

“…3 Nonetheless, staplers also have their share of disadvantages, including a high incidence of device malfunctions and adverse effects such as leakages and tissue tearing. 4,5 Moreover, the pointwise, tissue-penetrative modality of both sutures and staples is intrinsically damaging to tissues and can result in poor healing. Bioadhesives, referring to materials that can form adhesion with biological tissues, present a promising alternative to the traditional tissue attachment techniques.…”