California's Superbug Outbreak Just Got Worse As it emerges that the scope in question was being sold without FDA approval By Newser Editors, Newser Staff Posted Mar 5, 2015 7:55 AM CST 17 comments Comments This undated file photo provided by the US Food and Drug Administration shows the tip of an endoscopic retrograde cholangiopancreatography (ERCP) duodenoscope. (AP Photo/US Food and Drug Administration, File) (Newser) – The superbug outbreak that killed two people and sickened five more isn't constrained to UCLA's Ronald Reagan Medical Center. Another Los Angeles hospital is now reporting that four patients have been infected with antibiotic-resistant bacteria, and the scope that Cedars-Sinai Medical Center believes exposed its patients to carbapenem-resistant Enterobacteriaceae (CRE) is the same model thought to be responsible for the UCLA outbreak. Of the four Cedars-Sinai patients, three have been discharged and one died, though the hospital says CRE wasn't the cause of death in that case, CBS LA reports. Another 71 patients may have been exposed, NBC LA reports. The sole Olympus duodenoscope in question was used between August of last year and mid-February. The LA Times reports on what it terms a "startling admission" from the FDA this week concerning the difficult-to-clean Olympus scope: Olympus in 2010 redesigned its TJF-Q180V duodenoscope and then began selling the new model—without the FDA's OK. ABC News reports the FDA should have been alerted of the changes 90 days in advance of any marketing of it; it wasn't until March 2014 that the FDA asked Olympus to file for approval, which it did in October; the application is "pending." Per the Times, the FDA didn't yank the device in the interim because it's widely used, and the FDA feared such a move could spur a product shortage. CNN reports the design tweaks involve a portion of the device called the elevator channel—the portion that CNN says has been "implicated in the superbug outbreaks."