First Cited
Last Cited

Articles citing This Document (Page 1 of 4)

More Versus Better: Learning From the Medtronic Valiant Navion Recall2022
Retained Diabetes Devices—A Literature ReviewJournal of Diabetes Science and Technology
Clinical Issues—June 2022AORN Journal2022
The Role of Humans in Surgery AutomationInternational Journal of Social Robotics
FDA-Approved Innovative Duodenoscope Designs: Reports From the Manufacturer and User Facility Device Experience (MAUDE) DatabaseTechniques and Innovations in Gastrointestinal Endoscopy2021
A review of hospital based ventilator malfunctions reported to the FDA in 2021Journal of Mechanical Ventilation2021
Reporting Device-Associated Death Events to the FDA.JAMA Internal Medicine2022
Evaluation of cardiovascular implantable electronic device leads post implant: ElectroPhysiology Predictable And SuStainable Implementation Of National Registries (EP PASSION).Journal of Interventional Cardiac Electrophysiology2022
Ethics, Safety, and Closing Thoughts2022
Leadless Pacemaker Perforations: Clinical Consequences and Related Device and User Problems.Journal of Cardiovascular Electrophysiology2021
A review of the incidence, outcome and management of venous stent migration.Journal of Vascular Surgery: Venous and Lymphatic Disorders2022
Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and SoftwareFrontiers in Medicine2021
Adverse events related to AtriCure EPi-Sense Coagulation Device-Analysis of the FDA MAUDE databaseJournal of Cardiovascular Electrophysiology2021
Model of Functional Behavior of Healthcare Internet of Things Device Using Erlang Phase MethodCommunications in Computer and Information Science2020
Percutaneous arteriovenous fistula creation.Seminars in Vascular Surgery2021
Evaluating the presence of software-as-a-medical-device in FDA registrations (Preprint)JMIR Biomedical Engineering
Digitalisierung und Patientensicherheit2019
Specific Risks Related to Robotic Surgery: Are They Real?Advances in Intelligent Systems and Computing2019
Improving Safety of Medical Device Use Through Training2016
A Causality Analysis Framework for Component-Based Real-Time SystemsLecture Notes in Computer Science2013
Pain Complications of Mesh Surgery2013
Glistenings on intraocular lensesJournal of Refractive Surgery2012
Manufacturer and User Facility Device Experience (MAUDE) Database-FDA Adverse Event Report on STERRAD^|^reg; between 4 March 2008 and 26 January 2012Iryou Kikigaku (the Japanese Journal of Medical Instrumentation)2012
Hydrogen Peroxide Vapourised from Surface of Fiberscope after Low Temperature Hydrogen Peroxide SterilisationIryou Kikigaku (the Japanese Journal of Medical Instrumentation)2012
Adverse Event Reporting: Physicians, Manufacturers, and the Food and Drug Administration2005
Retrospective analysis of complications associated with dorsal root ganglion stimulation for pain relief in the FDA MAUDE databaseRegional Anesthesia and Pain Medicine2019
Electromagnetic Interference and Implantable Devices2007
Instrument Failures for the da Vinci Surgical System: a Food and Drug Administration MAUDE Database Study2013
Systems-Theoretic Safety Assessment of Robotic Telesurgical SystemsLecture Notes in Computer Science2015
Complications Associated With Nasopharyngeal COVID-19 Testing: An Analysis of the MAUDE Database and Literature ReviewAmerican Journal of Rhinology and Allergy2021
Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than DeathJAMA Internal Medicine2021
Characterizing Adverse Events of Cranioplasty Implants After Craniectomy: A Retrospective Review of the Federal Manufacturer and User Facility Device Experience DatabaseCureus2021
Total elbow arthroplasty failures in loosely linked implants: is humeral component aseptic loosening more common than previously thought?Seminars in Arthroplasty2021
Hydrogel Spacer Rectal Wall Infiltration Associated With Severe Rectal Injury and Related Complications After Dose Intensified Prostate Cancer Stereotactic Ablative Radiation TherapyAdvances in Radiation Oncology2021
Modes of failure with fractional flow reserve guidewires: Insights from the manufacturer and user facility device experience databaseWorld Journal of Cardiology2021
Robotic stapler use: Is it safe?-FDA database analysis across multiple surgical specialtiesPLoS ONE2021
Do not sell regulatory science shortNature Medicine2021
Safety and risk management of powered exoskeleton for spinal cord injuryJournal of Occupational Safety and Health2021
Measurement of transient electric field at the occurrence of electrostatic discharge when a charged metallic sphere approaches a grounded objectJournal of Occupational Safety and Health2021
The neurointerventional paradox: ensuring patient safety without restricting technological innovationJournal of NeuroInterventional Surgery2021
Analysis of Adverse Events Related to Impella Usage (from the Manufacturer and User Facility Device Experience and National Inpatient Sample Databases)American Journal of Cardiology2021
SAGES TAVAC safety and efficacy analysis confocal laser endomicroscopySurgical Endoscopy and Other Interventional Techniques2021
Hemodynamic effects of blood clots trapped by an inferior vena cava filterInternational Journal for Numerical Methods in Biomedical Engineering2020
High incidence of radiolucent lines at the implant-cement interface of a new total knee replacementANZ Journal of Surgery2020
CardioMEMS System in the Daily Management of Heart Failure: Review of Current Data and Technique of ImplantationExpert Review of Medical Devices2020
Use Trends and Adverse Reports of SelectSecure 3830 Lead Implantations in the United States: Implications for His Bundle PacingCirculation: Arrhythmia and Electrophysiology2020
Descriptive analysis of postmarket surveillance data for hip implantsPharmacoepidemiology and Drug Safety2020
Clinical Issues-November 2020AORN Journal2020
Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for Patient- and Circuit-Related Adverse Events Involving Extracorporeal Membrane OxygenationCardiovascular Revascularization Medicine2020
European Union medical device legislation, vigilance, and metrology system2020