| 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 |
| Medical Devices: Classification and Analysis of Faults Leading to Harms | Drug Safety | 2020 |
| Complications of Palatal Pillar Implants: An analysis of the MAUDE database and literature review | American Journal of Otolaryngology - Head and Neck Medicine and Surgery | 2020 |
| Rare electrosurgical complications in tonsillectomy: Analysis of national adverse event reporting | Laryngoscope | 2020 |
| Electrostatic hazards of charging of bedclothes and ignition in medical facilities | International Journal of Occupational Safety and Ergonomics | 2019 |
| Guidewire fracture during orbital atherectomy for peripheral artery disease: Insights from the Manufacturer and User Facility Device Experience database | Catheterization and Cardiovascular Interventions | 2019 |
| Robotic sacrocolpopexy: adverse events reported to the FDA over the last decade | International Urogynecology Journal | 2019 |
| Open source automated insulin delivery: addressing the challenge | Npj Digital Medicine | 2019 |
| Unrecognized maternal heart rate artefact in cases of perinatal mortality reported to the United States Food and Drug Administration from 2009 to 2019: a critical patient safety issue | BMC Pregnancy and Childbirth | 2019 |
| Elements of experiment safety in the laboratory | Journal of Chemical Health and Safety | 2019 |
| Clinical Issues-February 2019 | AORN Journal | 2019 |
| Analysis of the Attune tibial tray backside: A comparative retrieval study | Bone and Joint Research | 2019 |
| Techniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database | Cardiovascular Revascularization Medicine | 2019 |
| Endoscopic Bariatric Therapies: Intragastric Balloons, Tissue Apposition, and Aspiration Therapy | Current Treatment Options in Gastroenterology | 2019 |
| Lasers and energy-based devices marketed for vaginal rejuvenation: A cross-sectional analysis of the MAUDE database | Lasers in Surgery and Medicine | 2019 |
| Adverse events and modes of failure related to the FilterWire EZ Embolic Protection System: Lessons learned from an analytic review of the FDA MAUDE database | Catheterization and Cardiovascular Interventions | 2019 |
| Letter by Bilazarian et al. regarding the article, "Adverse events and modes of failure related to Impella RP: Insights from the Manufacturer and User Facility Device Experience (MAUDE) database" by Khalid et al | Cardiovascular Revascularization Medicine | 2019 |
| Response to the Letter from Dr. Sivanesan and Dr. Cohen | Neuromodulation | 2019 |
| Response to "Safety Analysis of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Pain" | Neuromodulation | 2019 |
| A use error taxonomy for improving human-machine interface design in medical devices | ACM SIGBED Review | 2019 |
| Duodenoscope-related infections: Overview and epidemiology | Techniques in Gastrointestinal Endoscopy | 2019 |
| Tailor-Made Design Guidelines for Human Factors and Usability for Medical Device Application: A Proposed Methodology | Proceedings of the Design Society International Conference on Engineering Design | 2019 |
| Biomaterials Evaluation: Conceptual Refinements and Practical Reforms | Therapeutic Innovation and Regulatory Science | 2019 |
| Safety of orogastric tubes in foregut and bariatric surgery | Surgical Endoscopy and Other Interventional Techniques | 2018 |
| Multicenter investigation of the incidence of inferior vena cava filter fracture | Japanese Journal of Radiology | 2018 |
| Pediatric Nasogastric Tube Placement and Verification: Best Practice Recommendations From the NOVEL Project | Nutrition in Clinical Practice | 2018 |
| Inferior Vena Cava Filters | | 2018 |
| Instrument Malfunction | | 2018 |
| Robot Failure | | 2018 |
| Barriers to implementation of the FUSE program | Surgical Endoscopy and Other Interventional Techniques | 2018 |
| The nature, magnitude, and reporting compliance of device-related events for intravenous patient-controlled analgesia in the FDA Manufacturer and User Facility Device Experience (MAUDE) database | Expert Opinion on Drug Safety | 2018 |
| Intragastric Balloon Treatment for Obesity: FDA Safety Updates | Advances in Therapy | 2018 |
| Investigating Complications Associated With Occipital Nerve Stimulation: A MAUDE Study | Neuromodulation | 2018 |
| Assessing Use Errors Related to the Interface Design of Electrosurgical Units | AORN Journal | 2018 |
| Instrument Error Codes and Diagnostic Serendipity | journal of applied laboratory medicine, The | 2017 |
| Anaphylactic Reaction during Implantation of Ovation Abdominal Stent Graft in Patients with Abdominal Aortic Aneurysm | Annals of Vascular Surgery | 2017 |
| Laboratory evaluation of a novel anaesthesia delivery device | Anaesthesia | 2017 |
| Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation | Journal of Artificial Organs | 2017 |
| Personal medical electronic devices and walk-through metal detector security systems: assessing electromagnetic interference effects | BioMedical Engineering OnLine | 2017 |
| Robotic Surgery: Risks vs. Rewards | AORN Journal | 2017 |
| Catheter-directed therapy as a treatment for submassive pulmonary embolism: A meta-analysis | Life Sciences | 2017 |
| Centrifuge bowl leak during extracorporeal photopheresis | Transfusion | 2017 |
| Adverse clinical events reported during Invisalign treatment: Analysis of the MAUDE database | American Journal of Orthodontics and Dentofacial Orthopedics | 2017 |
| The Polyanalgesic Consensus Conference (PACC): Recommendations for Intrathecal Drug Delivery: Guidance for Improving Safety and Mitigating Risks | Neuromodulation | 2017 |
| Commentary on: Mauf S, Jentzsch T, Laberke PJ, Thali MJ, Bartsch C. Why we need postmortem analysis of cardiac implantable electronic devices. J Forensic Sci 2016;61(4):988-92 | Journal of Forensic Sciences | 2017 |
| Safety of Rolled and Folded Cotton Blankets Warmed in 130°F and 200°F Cabinets | Journal of Perianesthesia Nursing | 2017 |
| Post-market surveillance to detect adverse events associated with Melody® valve implantation | Cardiology in the Young | 2017 |
| A Modern Magnetic Implant for Gastroesophageal Reflux Disease | Clinical Gastroenterology and Hepatology | 2017 |
| Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update | Gastrointestinal Endoscopy | 2017 |
| Effect of lead position and orientation on electromagnetic interference in patients with bipolar cardiovascular implantable electronic devices | Europace | 2017 |
| Postmarket Surveillance of Point-of-Care Glucose Meters through Analysis of Electronic Medical Records | Clinical Chemistry | 2016 |
| The TURis System for Transurethral Resection of the Prostate: A NICE Medical Technology Guidance | Applied Health Economics and Health Policy | 2016 |
| Beyond the VAD: Human Factors Engineering for Mechanically Assisted Circulation in the 21st Century | Artificial Organs | 2016 |
| Sling Procedures: Retropubic Hematoma | | 2016 |
| Taking a Device to Market: Regulatory and Commercial Issues | | 2016 |
| Bard Denali Filter Fractures | Journal of Vascular and Interventional Radiology | 2016 |
| Confronting systemic challenges in interoperable medical device safety, security & usability | Journal of Biomedical Informatics | 2016 |
| Fibroids and Infertility | Current Obstetrics and Gynecology Reports | 2016 |
| MR Safety Update 2015: Where Do the Risks Come From? | Current Radiology Reports | 2016 |
| Response | American Journal of Critical Care | 2016 |
| Comparing the EU and USA Medical Devices Vigilance Systems Transparency | IFMBE Proceedings | 2016 |
| Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data | PLoS ONE | 2016 |
| Bard Meridian filter fracture | CardioVascular and Interventional Radiology | 2015 |
| Methods and Issues to Consider for Detection of Safety Signals From Spontaneous Reporting Databases: A Report of the DIA Bayesian Safety Signal Detection Working Group | Therapeutic Innovation and Regulatory Science | 2015 |
| [Physical interactions in MRI: Some rules of thumb for their reduction] | Der Radiologe | 2015 |
| Lessons Learned from MRI Safety Events | Current Radiology Reports | 2015 |
| FDA Policy and Cardiovascular Medicine | Circulation | 2015 |
| Security challenges for medical devices | Communications of the ACM | 2015 |
| Inferior vena cava filters: current best practices | Journal of Thrombosis and Thrombolysis | 2015 |
| Are patients with cardiac implants protected against electromagnetic interference in daily life and occupational environment? | European Heart Journal | 2015 |
| No evidence for efficacy of radiofrequency ablation for treatment of gastroesophageal reflux disease: a systematic review and meta-analysis | Clinical Gastroenterology and Hepatology | 2015 |
| Surgical Energy-Based Device Injuries and Fatalities Reported to the Food and Drug Administration | Journal of the American College of Surgeons | 2015 |
| Reply: Differences in experience with a new delivery device for LAA ligation among various U.S. centers | Journal of the American College of Cardiology | 2015 |
| Electric morcellation-related reoperations after laparoscopic myomectomy and nonmyomectomy procedures | Journal of Minimally Invasive Gynecology | 2015 |
| Bard Denali inferior vena cava filter fracture and embolization resulting in cardiac tamponade: a device failure analysis | Journal of Vascular and Interventional Radiology | 2015 |
| FDA MAUDE data on complications with lasers, light sources, and energy-based devices | Lasers in Surgery and Medicine | 2015 |
| References | | 2015 |
| Evidence-based Health Informatics: How Do We Know What We Know? | Methods of Information in Medicine | 2015 |
| Clinical testing of a new medical device | | 2015 |
| MRI Conditional Devices, Safety, and Access: Choose Wisely and When You Come to the Fork in the Road, Take It | PACE - Pacing and Clinical Electrophysiology | 2015 |
| Transfusion Medicine Illustrated. Extracorporeal photopheresis drive tube leak due to end-user misload | Transfusion | 2015 |
| Flow-related noise in patients with ventriculoperitoneal shunt using gravitational adjustable valves | Acta Neurochirurgica | 2014 |
| Effectiveness of an electromagnetic feeding tube placement device in detecting inadvertent respiratory placement | American Journal of Critical Care | 2014 |
| Envisioning a Requirements Specification Template for Medical Device Software | Lecture Notes in Computer Science | 2014 |
| Pseudoaneurysm formation after medtronic freestyle porcine aortic bioprosthesis implantation: a word of caution | Annals of Thoracic Surgery | 2014 |
| Analysis of adverse events with Essure hysteroscopic sterilization reported to the Manufacturer and User Facility Device Experience database | Journal of Minimally Invasive Gynecology | 2013 |
| Inferior vena cava filters | JACC: Cardiovascular Interventions | 2013 |
| National efforts to improve health information system safety in Canada, the United States of America and England | International Journal of Medical Informatics | 2013 |
| The impact of atherosclerosis and vascular collagen on energy-based vessel sealing | Journal of Surgical Research | 2013 |
| Pulmonary embolism after endovenous thermal ablation of the saphenous vein | Seminars in Vascular Surgery | 2013 |
| The unacknowledged incidence of laparoscopic stapler malfunction | Surgical Endoscopy and Other Interventional Techniques | 2013 |
| Instrument Failures for the da Vinci Surgical System: a Food and Drug Administration MAUDE Database Study | Surgical Endoscopy and Other Interventional Techniques | 2013 |
| Inferior vena cava filter presenting as chronic low back pain | Clinical Imaging | 2012 |
| A rare allergy to a polyether dental impression material | Clinical Oral Investigations | 2012 |
| A standardized description of graft-containing meshes and recommended steps before the introduction of medical devices for prolapse surgery. Consensus of the 2nd IUGA Grafts Roundtable: optimizing safety and appropriateness of graft use in transvaginal pelvic reconstructive surgery | International Urogynecology Journal | 2012 |
| Entrapment of the StarClose Vascular Closure System after attempted common femoral artery deployment | CardioVascular and Interventional Radiology | 2012 |
| Intraoperative anaphylaxis to gelatin in topical hemostatic agents during anterior spinal fusion: a case report | Spine Journal | 2012 |
| Persistent abdominal pain caused by an inferior vena cava filter protruding into the duodenum and the aortic wall | Annals of Vascular Surgery | 2012 |
| Recent advances in MRI technology: Implications for image quality and patient safety | Saudi Journal of Ophthalmology | 2012 |
| [Computerized prescription for medical devices: examples, interest and limits] | Annales Pharmaceutiques Francaises | 2012 |
| Post-ablation tubal sterilization syndrome following NovaSure endometrial ablation: two case reports | Gynecological Surgery | 2012 |
