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- Systematic review of the technique of colorectal anastomosis.JAMA Surg. 2013; 148: 190-201
- Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial.Lancet. 2011; 377: 1514-1522
- Safety and efficacy of en bloc renal hilar vascular staple ligation: a meta-analysis.J Urol. 2017; 197: 175-181
- Surgical energy-based device injuries and fatalities reported to the Food and Drug Administration.J Am Coll Surg. 2015; 221: 197-205.e191
- Unnecessary histologic examination of stapler doughnuts at low anterior resection for rectal cancer: is it just a blame game?.Surgery. 2017; 162: 690
- No clinical benefit from routine histologic examination of stapler doughnuts at low anterior resection for rectal cancer.Surgery. 2017; 162: 147-151
Food and Drug Administration. Manufacturer and User Facility Device Experience Database (MAUDE). FDA.gov; 2019. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. Accessed March 15, 2019.
- Hidden FDA reports detail harm caused by scores of medical devices.https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/Date accessed: March 23, 2019
Food and Drug Administration. Safe use of surgical staplers and staples—Letter to health care providers [press release]. FDA.gov: Food and Drug Administration, Center for Devices and Radiological Health, March 8, 2019. https://public4.pagefreezer.com/browse/FDA/21-08-2022T08:51/https://www.fda.gov/medical-devices/letters-health-care-providers/safe-use-surgical-staplers-and-staples-letter-health-care-providers. Accessed December 15, 2022.
- Surgical stapler-associated fatalities and adverse events reported to the Food and Drug Administration.J Am Coll Surg. 2004; 199: 374-381
- Characterization of device-related interruptions in minimally invasive surgery: need for intraoperative data and effective mitigation strategies.Surg Endosc. 2019; 33: 717-723
- The unacknowledged incidence of laparoscopic stapler malfunction.Surg Endosc. 2013; 27: 86-89
Databases H. Healthcare Cost and Utilization Project (HCUP). Rockville, MD: Agency for Healthcare Research and Quality; https://www.hcup-us.ahrq.gov/databases.jsp. Accessed March 15, 2019.
National (Nationwide) Inpatient Sample (NIS) Database. https://www.hcup-us.ahrq.gov/db/nation/nis/nisdbdocumentation.jsp. Accessed March 15, 2019.
- Analysis of automated external defibrillator device failures reported to the Food and Drug Administration.Ann Emerg Med. 2012; 59: 103-111
- Global adverse event reports of breast implant-associated ALCL: an international review of 40 government authority databases.Plast Reconstr Surg. 2017; 139: 1029-1039
- Complications after laparoscopic gastric bypass: a review of 3464 cases.Arch Surg. 2003; 138: 957-961
- Vascular management during live donor nephrectomy: an online survey among transplant surgeons.Am J Transplant. 2015; 15: 1701-1707
- Hilar control during laparoscopic donor nephrectomy: practice patterns in Canada.Can Urol Assoc J. 2017; 11: 321-324
- Common side closure type, but not stapler brand or oversewing, influences side-to-side anastomotic leak rates.Am J Surg. 2017; 213: 590-595
- High incidence of technical errors involving the EEA circular stapler: a single institution experience.J Am Coll Surg. 2010; 210: 331-335
- Endo GIA stapler malfunction in a small bowel loop resection.J Surg Case Rep. 2018; 2018: rjy281
- Salvaging a linear staple line defect in ultra-low anterior resection.Tech Coloproctol. 2007; 11: 266-267
Group OLoEW. Oxford Center for Evidence-Based Medicine 2011 Levels of Evidence. Oxford, England. https://www.cebm.ox.ac.uk/resources/levels-of-evidence/oxford-centre-for-evidence-based-medicine-levels-of-evidence-march-2009. Accessed December 15, 2022.
- Good to Great: Why Some Companies Make the Leap—And Others Do Not.HarperBusiness, New York, NY2001
- The FDA’s MAUDE: useful insights for medical devices.https://www.americanbar.org/groups/litigation/committees/mass-torts/practice/2017/manufacture-and-user-facility-device-experience/Date: 2017Date accessed: March 23, 2019
- Mechanisms of hemostatic failure during laparoscopic nephrectomy: review of Food and Drug Administration database.Urology. 2007; 70: 888-892
- Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data.Am Heart J. 2018; 198: 64-74
- Safety and procedural success of left atrial appendage exclusion with the lariat device: a systematic review of published reports and analytic review of the FDA MAUDE Database.JAMA Intern Med. 2015; 175: 1104-1109
- Overview of the nationwide ambulatory surgery sample.https://www.hcup-us.ahrq.gov/nassoverview.jspDate: 2021Date accessed: October 1, 2022
- Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study.BMJ. 2020; 370: m2917
- Classification of intraoperative adverse events in visceral surgery.Surgery. 2022; 171: 1570-1579