Advertisement

Mortality related to the use of stapler devices and clip appliers: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience database

Published:December 21, 2022DOI:https://doi.org/10.1016/j.surg.2022.11.013

      Abstract

      Background

      Surgical staplers and clip appliers are commonly used and have a potential to malfunction, which may result in serious injury or death. These events are self-reported to the Food and Drug Administration and compiled in the Food and Drug Administration’s Manufacturer and User Facility Device Experience database. This study characterizes mortality related to surgical stapler and clip applier failure reported in the Food and Drug Administration’s Manufacturer and User Facility Device Experience database.

      Methods

      The Food and Drug Administration’s Manufacturer and User Facility Device Experience database was reviewed between 1992 and 2016 for medical device reports related to surgical staplers and clip appliers filed under the following product codes: GAG, FZP, GDO, GDW, KOG, and GCJ. Adverse events including death and the type of device failure were reviewed. Temporal trends in reported deaths related to device failure were analyzed and the Healthcare Cost and Utilization Project database was used to adjust for annual surgical case volume using linear regression analysis.

      Results

      A total of 75,415 malfunctions, 21,115 injuries, and 676 deaths were associated with the use of surgical stapler and clip applier devices. Most deaths occurred postoperatively (N = 516, 76.3%) and were due to infection/sepsis (N = 89, 17.2%) or vascular injuries (N = 110, 21.3%). Intraoperative mortality (N = 79, 11.7%) was primarily due to vascular injuries (N = 73, 92.4%). Device failures resulting in death were noted both intraoperatively (N = 268, 39.6%) and postoperatively (N = 325, 48.1%). In post hoc root cause analysis, a surgical stapler and clip applier device problem was the most common attributed cause of death (N = 238, 65.4%). In the linear regression analysis, there was a significant increase in the mortality from device failure in the study period after adjusting for annual surgical volume (P < .01).

      Conclusion

      Mortality related to the use of surgical staplers and clip appliers is increasing. Most deaths occurred postoperatively, and an increased awareness of potential life-threatening complications is warranted when these devices are used.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Surgery
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Slieker J.C.
        • Daams F.
        • Mulder I.M.
        • Jeekel J.
        • Lange J.F.
        Systematic review of the technique of colorectal anastomosis.
        JAMA Surg. 2013; 148: 190-201
        • Diener M.K.
        • Seiler C.M.
        • Rossion I.
        • et al.
        Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial.
        Lancet. 2011; 377: 1514-1522
        • Lai W.S.
        • Rais-Bahrami S.
        Safety and efficacy of en bloc renal hilar vascular staple ligation: a meta-analysis.
        J Urol. 2017; 197: 175-181
        • Overbey D.M.
        • Townsend N.T.
        • Chapman B.C.
        • et al.
        Surgical energy-based device injuries and fatalities reported to the Food and Drug Administration.
        J Am Coll Surg. 2015; 221: 197-205.e191
        • Spartalis E.
        • Moris D.
        • Athanasiou A.
        • Kykalos S.
        • Dimitroulis D.
        Unnecessary histologic examination of stapler doughnuts at low anterior resection for rectal cancer: is it just a blame game?.
        Surgery. 2017; 162: 690
        • Sugrue J.
        • Dagbert F.
        • Park J.
        • et al.
        No clinical benefit from routine histologic examination of stapler doughnuts at low anterior resection for rectal cancer.
        Surgery. 2017; 162: 147-151
      1. 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.

        • Jewett C.
        Hidden FDA reports detail harm caused by scores of medical devices.
      2. 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.

        • Brown S.L.
        • Woo E.K.
        Surgical stapler-associated fatalities and adverse events reported to the Food and Drug Administration.
        J Am Coll Surg. 2004; 199: 374-381
        • Jung J.J.
        • Kashfi A.
        • Sharma S.
        • Grantcharov T.
        Characterization of device-related interruptions in minimally invasive surgery: need for intraoperative data and effective mitigation strategies.
        Surg Endosc. 2019; 33: 717-723
        • Kwazneski 2nd, D.
        • Six C.
        • Stahlfeld K.
        The unacknowledged incidence of laparoscopic stapler malfunction.
        Surg Endosc. 2013; 27: 86-89
      3. 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.

      4. National (Nationwide) Inpatient Sample (NIS) Database. https://www.hcup-us.ahrq.gov/db/nation/nis/nisdbdocumentation.jsp. Accessed March 15, 2019.

        • DeLuca Jr., L.A.
        • Simpson A.
        • Beskind D.
        • et al.
        Analysis of automated external defibrillator device failures reported to the Food and Drug Administration.
        Ann Emerg Med. 2012; 59: 103-111
        • Srinivasa D.R.
        • Miranda R.N.
        • Kaura A.
        • et al.
        Global adverse event reports of breast implant-associated ALCL: an international review of 40 government authority databases.
        Plast Reconstr Surg. 2017; 139: 1029-1039
        • Podnos Y.D.
        • Jimenez J.C.
        • Wilson S.E.
        • Stevens C.M.
        • Nguyen N.T.
        Complications after laparoscopic gastric bypass: a review of 3464 cases.
        Arch Surg. 2003; 138: 957-961
        • Janki S.
        • Verver D.
        • Klop K.W.
        • et al.
        Vascular management during live donor nephrectomy: an online survey among transplant surgeons.
        Am J Transplant. 2015; 15: 1701-1707
        • McGregor T.B.
        • Patel P.
        • Chan G.
        • Sener A.
        Hilar control during laparoscopic donor nephrectomy: practice patterns in Canada.
        Can Urol Assoc J. 2017; 11: 321-324
        • Fleetwood V.A.
        • Gross K.N.
        • Alex G.C.
        • et al.
        Common side closure type, but not stapler brand or oversewing, influences side-to-side anastomotic leak rates.
        Am J Surg. 2017; 213: 590-595
        • Offodile II, A.C.
        • Feingold D.L.
        • Nasar A.
        • Whelan R.L.
        • Arnell T.D.
        High incidence of technical errors involving the EEA circular stapler: a single institution experience.
        J Am Coll Surg. 2010; 210: 331-335
        • Perinjelil V.
        • Nkansah-Amankra K.
        • Maraqa T.
        • Mercer L.
        • Sachwani-Daswani G.
        Endo GIA stapler malfunction in a small bowel loop resection.
        J Surg Case Rep. 2018; 2018: rjy281
        • Tan W.S.
        • Ng K.H.
        • Eu K.W.
        Salvaging a linear staple line defect in ultra-low anterior resection.
        Tech Coloproctol. 2007; 11: 266-267
      5. 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.

        • Collins J.C.
        Good to Great: Why Some Companies Make the Leap—And Others Do Not.
        HarperBusiness, New York, NY2001
        • McGrath P.J.
        The FDA’s MAUDE: useful insights for medical devices.
        • Hsi R.S.
        • Saint-Elie D.T.
        • Zimmerman G.J.
        • Baldwin D.D.
        Mechanisms of hemostatic failure during laparoscopic nephrectomy: review of Food and Drug Administration database.
        Urology. 2007; 70: 888-892
        • Galper B.Z.
        • Beery D.E.
        • Leighton G.
        • Englander L.L.
        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
        • Chatterjee S.
        • Herrmann H.C.
        • Wilensky R.L.
        • et al.
        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
        • Agency for Healthcare Research and Quality
        Overview of the nationwide ambulatory surgery sample.
        https://www.hcup-us.ahrq.gov/nassoverview.jsp
        Date: 2021
        Date accessed: October 1, 2022
        • Dell-Kuster S.
        • Gomes N.V.
        • Gawria L.
        • et al.
        Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study.
        BMJ. 2020; 370: m2917
        • Gawria L.
        • Rosenthal R.
        • van Goor H.
        • et al.
        Classification of intraoperative adverse events in visceral surgery.
        Surgery. 2022; 171: 1570-1579