Discussions in Infection Control

An independent site by Lawrence F Muscarella PhD -- a national authority on the causes and prevention of healthcare-associated infections and related errors.

Category: Device Recalls

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)

Guidance to Prevent Adverse Events, Including Mucosal Tissue Injuries, 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.

Bronchoscopes Carbapenem-Resistant Enterobacteriaceae (CRE) Colistin-Resistant Bacteria Device Recalls Duodenoscopes Endoscope Reprocessing Klebsiella pneumoniae Medical Device Reports (MDRs) Multidrug Resistant Strains O-ring Contamination Pseudomonas aeruginosa Superbugs

A Bronchoscope is Linked Again in the U.S. to an Outbreak of the Feared ‘CRE’ Superbug Is enough being done to improve safety? The recall of several bronchoscope models is also discussed.

October 1, 2018 Lawrence F Muscarella PhD

October 1, 2018 (updated: Oct. 5, 2018; edited: Oct. 8, 2020) — A bronchoscope’s use has been linked again to a “superbug” outbreak, this time involving “multiple patients,” according to…

DEC Duodenoscope Duodenoscopes Duodenoscopes Olympus TJF-160F Pentax ED-3490TK Pentax ED34-i10T Pentax ED34-i10T2 Single-Use Disposable Devices

FDA Clears A Duodenoscope with a Detachable Cap Almost 20 years ago, the FDA cleared two other duodenoscope models with a reusable distal cover for sale in the U.S.

September 25, 2017 Lawrence F Muscarella PhD

Sept. 25, 2017 (Monday; 11:47am) — The FDA announced last week that it has “cleared the first duodenoscope with a disposable distal cap” for use in U.S. hospitals, calling this…

You missed

Adverse Event Reports Case Reviews Colonoscopes Colonoscopy Endoscope Reprocessing Risk Assessment Salmonella

17 U.S. Patients Were Exposed in December to a Colonoscope Contaminated with Salmonella Bacteria, FDA Reports Reveal

January 24, 2024 Lawrence F Muscarella PhD
Adverse Event Reports Ambu Centers for Medicare and Medicaid Services (CMS) COVID-19 Endoscope Reprocessing Rebuttals Single-Use TPT Medicare Payment Status

In Support of Patient Safety, Healthcare Access, and Medicare Payment for a Single-Use Bronchoscope Model

January 8, 2024 Lawrence F Muscarella PhD
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)

Guidance to Prevent Adverse Events, Including Mucosal Tissue Injuries, When Using Duodenoscopes with a Single-Use Endcap

August 2, 2023 Lawrence F Muscarella PhD
Adverse Event Reports Candida auris Carbapenem-Resistant Enterobacteriaceae (CRE) Duodenoscopes Endoscope Reprocessing Escherichia coli Gastroscopes MAUDE Medical Device Reports (MDRs) Risk Assessment Single-Use Disposable Devices

Gastroscopes Have Been Linked to A Cluster of Resistant E. coli Infections — Is the Risk Sufficiently Recognized?

January 6, 2023 Lawrence F Muscarella PhD