5. Olympus – Endoscope
via endoscopyworld.com
In many cases, a routine endoscopy is carried out to confirm a diagnosis, and it often goes without a hitch. However, one tool in this routine process has recently developed a very bad reputation.
In one case, the Olympus TJF-Q180V duodenoscope used at the Ronald Reagan Medical Center in California, has been implicated in two deaths. It has also been blamed for the spread of the antibiotic resistant superbug, Carbapenem-resistant Enterobacteriaceae (CRE) in up to 200 cases. Like many superbugs, infected patients have a high mortality rate. In CRE, 50% of all infected patients die.
Investigations uncovered that the FDA never cleared the scope for use, at all. The model in question contains many grooves, which makes a thorough clean quite difficult. A poor clean raises the risk of bacteria being transferred from patient to patient.
The manufacturer, Olympus, is currently facing charges of selling a product without FDA clearance, negligence and causing wrongful death. With the scope being implicated in deaths from more hospitals across the country, the number of suits are bound to rise in the coming months.
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