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

Endoscope Infection Risk Highlighted in FDA Warning

tsf-no-longer-accepting-cases

December 19, 2014 — Karl Storz Endovision, Inc., one of the largest manufacturers of endoscopes, has received a warning letter after the FDA received complaints about cleaning brushes not fitting inside properly.

The FDA was specifically concerned about the Flex-X2 Ureteroscope, which is a long tube that is passed through the urethra, bladder, and then into the upper urinary tract.

The device consists of a long, thin tube that has a light and a camera on the end. It is used to find the cause of urinary problems, such as kidney stones or cancer.

Because endoscopes are used in highly-contaminated areas of the body, they must be thoroughly cleaned and disinfected between uses to prevent transmission of diseases, such as HIV and Hepatitis C. Unfortunately, cleaning endoscopes is labor-intensive and difficult.

The first step is physically scrubbing the endoscope to remove debris, which requires a properly-fitting brush. After this step, the endoscope is disinfected with an enzymatic cleaner and a high-level disinfectant.

Even after cleaning, it is not uncommon for endoscopes to remain contaminated. In October, the Chicago Sun Times reported that a hospital in Illinois was hit with a lawsuit after an outbreak of infections.

The woman claims she was one of 44 people who developed the same bacterial infection after endoscopies and other procedures. She blames her infection on an endoscope that was contaminated with NDM producing CRE, a common pathogen found in hospitals.

In 2011, a hospital in New Orleans was hit with a class action after hundreds of patients were exposed to diseases when an endoscope was not sanitized between October 8 and December 1, 2010.

 

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.