Warning letters (FDA) Archives - Discussions in Infection Control

Fri. Jun 20th, 2025

Adverse Event Reports Food and Drug Administration Food Drug and Cosmetic Act Medical Device Reports (MDRs) Misbranded Devices Patient Notification Warning letters (FDA)

Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions

May 13, 2025 Lawrence F Muscarella PhD

Hundreds of thousands of reports from device manufacturers describing an adverse event during a recent 3-and-a-half-year period were submitted to FDA late, a March study has found, raising questions about…

Adulterated Devices Adverse Event Reports Device Recalls Duodenoscopes with Disposable Components Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Esophagogastroduodenoscopy (EGD) FUJIFILM ED-580XT MAJ-2315 Misbranded Devices Olympus TJF-Q190V Single-Use Endcap with Elevator Warning letters (FDA)

Esophageal Tissue Tears and Other Adverse Events Reported When Using Duodenoscopes with a Single-Use Endcap

August 2, 2023 Lawrence F Muscarella PhD

Updated guidance is provided to reduce the risks of mucosal injuries and the endcap becoming detached and falling off inside the patient when using a duodenoscope with a single-use endcap.

522 Order Carbapenem-Resistant Enterobacteriaceae (CRE) Colistin Duodenoscopes Food Drug and Cosmetic Act FUJIFILM MCR-1 gene Medical Device Reports (MDRs) Olympus Pentax Postmarket surveillance studies Warning letters (FDA)

FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

March 15, 2018 Lawrence F Muscarella PhD

March 15, 2018 (1:14 pm) — The three manufacturers of duodenoscopes sold in the U.S. have not complied with the requirements of an order the FDA issued to each in…

You missed

Adverse Event Reports Food and Drug Administration Food Drug and Cosmetic Act Medical Device Reports (MDRs) Misbranded Devices Patient Notification Warning letters (FDA)

Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions

Esophageal Tissue Tears and Other Adverse Events Reported When Using Duodenoscopes with a Single-Use Endcap

FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

You missed

Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions

Endoscopy Patients at Vanderbilt Potentially Exposed to HIV and Hepatitis, County Officials Have Confirmed

Dr. Muscarella’s Recent Recommendations to Medicare to Prevent Hospital-Acquired Infections

15 Patients Infected with Mycobacteria After Undergoing Cosmetic Surgery at a South Florida Clinic

Category: Warning letters (FDA)

Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions

Esophageal Tissue Tears and Other Adverse Events Reported When Using Duodenoscopes with a Single-Use Endcap

FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

You missed

Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions

Endoscopy Patients at Vanderbilt Potentially Exposed to HIV and Hepatitis, County Officials Have Confirmed

Dr. Muscarella’s Recent Recommendations to Medicare to Prevent Hospital-Acquired Infections

15 Patients Infected with Mycobacteria After Undergoing Cosmetic Surgery at a South Florida Clinic