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Intraoperative robotic surgical system-related problems in robot-assisted thoracoscopic surgery.
Gen Thorac Cardiovasc Surg
September 2024
Department of Thoracic Surgery, Tokyo Women's Medical University, 8-1 Kawada-Cho, Shinjuku-Ku, Tokyo, 162-8666, Japan.
Background: Malfunctions of robotic instruments during robotic surgery are well known to occur; however, detailed reports on the inherent problems associated with robotic instruments and robotic surgical systems are scarce. The objective of this study was to retrospectively investigate the intraoperative problems associated with robotic surgical systems and robotic instruments.
Materials And Methods: This was a single-center retrospective study.
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.
Surgery
May 2023
Department of Urology, Massachusetts General Hospital, Boston, MA.
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.
View Article and Find Full Text PDFStapler Malfunctions in Bariatric Surgery: An Analysis of the MAUDE Database.
JSLS
March 2022
Department of Surgery, Texas Tech HSC Paul Foster School of Medicine, El Paso, TX, USA.
Background: Staple line leaks are a serious problem in bariatric surgery and a major cause of serious morbidity and mortality. Adverse events caused by medical devices are reported to the Food and Drug Administration which maintains the Manufacturer and User Facility Device Experience (MAUDE) database. We examined adverse stapler events reported to the MAUDE database, specifically with regards to bariatric surgery.
View Article and Find Full Text PDFRobotic stapler use: Is it safe?-FDA database analysis across multiple surgical specialties.
PLoS One
November 2021
Department of Urology and Renal Transplantation, University of Toledo, Toledo, OH, United States of America.
Introduction: Robotic-assisted techniques are common across many surgical subspecialties. While robotic stapling offers increased surgeon control, there is limited information on surgical complications related to robotic stapler use.
Methods: We reviewed the FDA's MAUDE database for adverse events related to robotic stapler use.
Revealing the scope of surgical device malfunctions: Analysis of the "hidden" Food and Drug Administration device database.
Am J Surg
June 2021
Trauma Service, Scripps Mercy Hospital, 4077 Fifth Avenue, San Diego, CA, 92103, USA. Electronic address:
Background: We compared surgical device malfunction reports in the Food and Drug Administration (FDA) public Manufacturer and User Facility Device Experience (MAUDE) with those in the FDA nonpublic Alternative Summary Reporting (ASR).
Methods: General surgery device product code categories in MAUDE and ASR from 1999 to 2018 were identified. Changes in the rates of categories and adverse events were evaluated by Poisson regression.
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