More Versus Better: Learning From the Medtronic Valiant Navion Recall | | 2022 |
Retained Diabetes Devices—A Literature Review | Journal of Diabetes Science and Technology | |
Clinical Issues—June 2022 | AORN Journal | 2022 |
The Role of Humans in Surgery Automation | International Journal of Social Robotics | |
FDA-Approved Innovative Duodenoscope Designs: Reports From the Manufacturer and User Facility Device Experience (MAUDE) Database | Techniques and Innovations in Gastrointestinal Endoscopy | 2021 |
A review of hospital based ventilator malfunctions reported to the FDA in 2021 | Journal of Mechanical Ventilation | 2021 |
Reporting Device-Associated Death Events to the FDA. | JAMA Internal Medicine | 2022 |
Evaluation of cardiovascular implantable electronic device leads post implant: ElectroPhysiology Predictable And SuStainable Implementation Of National Registries (EP PASSION). | Journal of Interventional Cardiac Electrophysiology | 2022 |
Ethics, Safety, and Closing Thoughts | | 2022 |
Leadless Pacemaker Perforations: Clinical Consequences and Related Device and User Problems. | Journal of Cardiovascular Electrophysiology | 2021 |
A review of the incidence, outcome and management of venous stent migration. | Journal of Vascular Surgery: Venous and Lymphatic Disorders | 2022 |
Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software | Frontiers in Medicine | 2021 |
Adverse events related to AtriCure EPi-Sense Coagulation Device-Analysis of the FDA MAUDE database | Journal of Cardiovascular Electrophysiology | 2021 |
Model of Functional Behavior of Healthcare Internet of Things Device Using Erlang Phase Method | Communications in Computer and Information Science | 2020 |
Percutaneous arteriovenous fistula creation. | Seminars in Vascular Surgery | 2021 |
Evaluating the presence of software-as-a-medical-device in FDA registrations (Preprint) | JMIR Biomedical Engineering | |
Digitalisierung und Patientensicherheit | | 2019 |
Specific Risks Related to Robotic Surgery: Are They Real? | Advances in Intelligent Systems and Computing | 2019 |
Improving Safety of Medical Device Use Through Training | | 2016 |
A Causality Analysis Framework for Component-Based Real-Time Systems | Lecture Notes in Computer Science | 2013 |
Pain Complications of Mesh Surgery | | 2013 |
Glistenings on intraocular lenses | Journal of Refractive Surgery | 2012 |
Manufacturer and User Facility Device Experience (MAUDE) Database-FDA Adverse Event Report on STERRAD^|^reg; between 4 March 2008 and 26 January 2012 | Iryou Kikigaku (the Japanese Journal of Medical Instrumentation) | 2012 |
Hydrogen Peroxide Vapourised from Surface of Fiberscope after Low Temperature Hydrogen Peroxide Sterilisation | Iryou Kikigaku (the Japanese Journal of Medical Instrumentation) | 2012 |
Adverse Event Reporting: Physicians, Manufacturers, and the Food and Drug Administration | | 2005 |
Retrospective analysis of complications associated with dorsal root ganglion stimulation for pain relief in the FDA MAUDE database | Regional Anesthesia and Pain Medicine | 2019 |
Electromagnetic Interference and Implantable Devices | | 2007 |
Instrument Failures for the da Vinci Surgical System: a Food and Drug Administration MAUDE Database Study | | 2013 |
Systems-Theoretic Safety Assessment of Robotic Telesurgical Systems | Lecture Notes in Computer Science | 2015 |
Complications Associated With Nasopharyngeal COVID-19 Testing: An Analysis of the MAUDE Database and Literature Review | American Journal of Rhinology and Allergy | 2021 |
Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death | JAMA Internal Medicine | 2021 |
Characterizing Adverse Events of Cranioplasty Implants After Craniectomy: A Retrospective Review of the Federal Manufacturer and User Facility Device Experience Database | Cureus | 2021 |
Total elbow arthroplasty failures in loosely linked implants: is humeral component aseptic loosening more common than previously thought? | Seminars in Arthroplasty | 2021 |
Hydrogel Spacer Rectal Wall Infiltration Associated With Severe Rectal Injury and Related Complications After Dose Intensified Prostate Cancer Stereotactic Ablative Radiation Therapy | Advances in Radiation Oncology | 2021 |
Modes of failure with fractional flow reserve guidewires: Insights from the manufacturer and user facility device experience database | World Journal of Cardiology | 2021 |
Robotic stapler use: Is it safe?-FDA database analysis across multiple surgical specialties | PLoS ONE | 2021 |
Do not sell regulatory science short | Nature Medicine | 2021 |
Safety and risk management of powered exoskeleton for spinal cord injury | Journal of Occupational Safety and Health | 2021 |
Measurement of transient electric field at the occurrence of electrostatic discharge when a charged metallic sphere approaches a grounded object | Journal of Occupational Safety and Health | 2021 |
The neurointerventional paradox: ensuring patient safety without restricting technological innovation | Journal of NeuroInterventional Surgery | 2021 |
Analysis of Adverse Events Related to Impella Usage (from the Manufacturer and User Facility Device Experience and National Inpatient Sample Databases) | American Journal of Cardiology | 2021 |
SAGES TAVAC safety and efficacy analysis confocal laser endomicroscopy | Surgical Endoscopy and Other Interventional Techniques | 2021 |
Hemodynamic effects of blood clots trapped by an inferior vena cava filter | International Journal for Numerical Methods in Biomedical Engineering | 2020 |
High incidence of radiolucent lines at the implant-cement interface of a new total knee replacement | ANZ Journal of Surgery | 2020 |
CardioMEMS System in the Daily Management of Heart Failure: Review of Current Data and Technique of Implantation | Expert Review of Medical Devices | 2020 |
Use Trends and Adverse Reports of SelectSecure 3830 Lead Implantations in the United States: Implications for His Bundle Pacing | Circulation: Arrhythmia and Electrophysiology | 2020 |
Descriptive analysis of postmarket surveillance data for hip implants | Pharmacoepidemiology and Drug Safety | 2020 |
Clinical Issues-November 2020 | AORN Journal | 2020 |
Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for Patient- and Circuit-Related Adverse Events Involving Extracorporeal Membrane Oxygenation | Cardiovascular Revascularization Medicine | 2020 |
European Union medical device legislation, vigilance, and metrology system | | 2020 |