Call Today for a FREE Confidential Case Review
Toll-Free 24/7 (866) 920-0753

FDA Warns Endoscope-Makers for Delaying Infection Reports


August 17, 2015 — The FDA has issued warning letters to all three major endoscope manufacturers, including warning Olympus Corp. for waiting years to report an outbreak of bacterial infections.

In May 2012, Olympus was notified that 16 patients were infected with the bacteria Pseudomonas aeruginosa after undergoing endoscopic procedures, according to the warning letter. However, the outbreak was not reported to the FDA until May 2015.

The FDA also issued warning letters to Fujifilm and Pentax.

Pentax also failed to report that their scopes were linked to cases of antibiotic-resistant Carbapenem-resistant Enterobacteriaceae (CRE) infections within 30 days, as is required by law. Olympus scopes were linked to deadly outbreaks of CRE at hospitals in Washington and California earlier this year.

There also seems to be a problem with unapproved scopes. The Olympus duodenoscope linked to several deadly infection outbreaks had been on the market since 2010 without proper clearance.

According to the warning letters, Fujifilm’s newest endoscope does not have permission to be on the market. Pentax may also have an unapproved scope on the market, according to Bloomberg.


Free Case Evaluation

The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.

No matter what type of case you have, you may contact us with confidence by filling out the email contact form below or calling us directly by dialing toll free 24 hrs/day (866) 920-0753.