Olympus Endoscopes Linked to Superbug Outbreaks, Deaths
Every year, more than 50,000 Americans undergo Endoscopic Retrograde Cholangiopancreatography, a procedure that examines the bile duct of the body’s gastrointestinal system. Many of these procedures are performed with an Olympus duodenoscope . This medical device was neverapproved by the FDA. So far, dozens of patients have been infected with carbapenem-resistant Enterobacteriaceae (CRE), a deadly superbug, following routine endoscopic procedures.
The CRE outbreak began in Southern California at Ronald Reagan UCLA Medical Center. Between October and January, seven patients contracted the superbug after undergoing routine endoscopic treatments. Two of the CRE-infected patients died. Medical experts believe that the bacteria remained in model TJF-Q180V duodenoscopes manufactured by Olympus, even after staff thoroughly disinfected the devices.
- Pentax Medical
Nearby at Cedars-Sinai Medical Center in Los Angeles, another four patients were infected with the deadly bacteria. The patients all underwent an endoscopic procedure, each with the same medical scope. The scope was disinfected between procedures, but the device design prevented full sterilization of the medical instrument. Due to the outbreaks, hundreds of additional patients have been contacted, made aware of the outbreak and have been offered CRE-screening kits free of charge.
Unfortunately, the FDA didn’t notice until early 2014 that it never cleared the duodenoscopes for sale & use. Olympus claims that it wasn’t aware that approval was required. The company has now applied for permission, but the FDA has not yet granted it.
If you or a loved one has contracted CRE following an endoscopic procedure, contact the defective medical device attorneys at Nadrich & Cohen, LLP for a free consultation. For decades, our law firm has been fighting on behalf of injured patients. Contact us now, fora free case evaluation.
- CRE Infection (antibiotic resistant) also referred to “Superbug”
- Organ Failure or Loss of Organs