Trends and incidence of reported events associated with staplers: An analysis of the food and drug administration's manufacturer and user facility device experience database

Introduction & Objectives: To summarize medical device reports (MDRs) between 2012 and 2022 relating to staplers within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). Material(s) and Method(s): The MAUDE database was analyzed for all MDRs relating to each FDA-approved stapler for the last ten years. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific staplers and reported events as detailed by the MDRs. All data is de-identified and in compliance with the Health Insurance Portability and Accountability Act (HIPAA). No further data was available in the database. Pooled Relative risk was used to compare data. Result(s): Overall, 712 reports were retrieved in 10 years, between 2013 and 2015 a higher number of events were reported. In all, 413/712 (58%) were reported as malfunction of the device while 292/712 (41%) as injury. The most frequently reported adverse events (AEs) were Misfire (111/712: 15.6%), Failure to form staple (92/712: 12.9%), Mechanical jam (76/712: 10.7%) and Failure to fire (72/712: 10.1%). In terms of manufacturer: 401/712 (56%) were Covidien, 172/712 (24%) were Teleflex Medical and 139/712 (19.5%) were Ethicon Instruments. When comparing on disproportional analysis the different manufacturers, in terms of Misfire, Covidien presented the better profile when compared to Teleflex Medical and Ethicon (PRR= 0.32-0.65;p<0.05);in terms of failure to form staple Teleflex Medical presented the better profile when compared to Covidien and Ethicon (PRR 0.27-0.49;p<0.05);in terms of mechanical jam Covidien and Ethicon presented the best profile compared to Teleflex Medical (PRR 0.10-0.15;p<0.05). Lastly, in terms of failure to fire Teleflex presented the best profile (0% of events). Table 1: Trends and principal patient problems reported by the MAUDE database. Conclusion(s): Standing to MAUDE database the most frequent complications related to stapler are misfire, failure to form staple, mechanical jam and failure to fire. As well, the reported adverse events vary among the different manufacturers. [Figure presented]Copyright © 2023.

Impact of COVID-19 pandemic on the urologic practice in the emergency departments in Italy

Abstract The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes, coronavirus disease 2019 (COVID-19), are causing a rapid and tragic health emergency worldwide [1,2]. Italy was the first European country to experience a virus outbreak, starting on Feb, 21st 2020. It resulted in national quarantine, and the official lockdown of the country's non-essential businesses and services began on Mar, 9th 2020. Although several reports are available in the literature on recommendations for reorganization of the clinical and surgical activities [3-7], to our knowledge, no data is available on the effective impact of COVID-19 pandemic on the outcomes of other medical conditions.