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# Foreign Bug Outbreak Linked to Olympus Scope: LA Times
- URL: https://www.fdaweb.com/foreign-bug-outbreak-linked-to-olympus-scope-la-times/
- Published: 2017-03-24T12:00:00.000Z
- Updated: 2026-09-14T22:13:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138290

Recent medical device reports are linking a superbug outbreak at a foreign health facility to a duodenoscope that Olympus modified last year in an move to reduce its risk of spreading bacteria between patients, according to a [article](http://www.latimes.com/topic/health/food-drug-administration-ORGOV0000136161-topic.html?ref=fdaweb.com) by *LA Times* investigative reporter **Melody Petersen**. Five patients treated with the modified device tested positive for the same potentially deadly bacteria, according to a report filed with FDA, the article says. One patient died, but the report blamed it on the person’s pre-existing condition rather than the infection. “American hospitals are currently using about 4,400 of the devices that Olympus voluntarily recalled last year to replace a small mechanism linked to deadly outbreaks around the world,” it says.

  
Last year, FDA cleared an Olympus 510(k) for the TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections ([see story](https://www.fdaweb.com/login.php?sa=v&aid=D5134450&searchWords=duodenoscope&cate=S&stid=%241%24Ac2.Jx3.%24G0g9tBOUVEawx6c9DMl9F1)). The company decided to recall its original model currently being used in health care facilities and make the needed repair, an agency news [release ](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm481956.htm?ref=fdaweb.com)said at the time. The clearance follows a 2014 request from FDA for Olympus to obtain 510(k) clearance for its “closed” elevator channel model, which had never been cleared for marketing. In a [letter](http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM436587.pdf?ref=fdaweb.com) sent to Olympus, the agency stated that design changes to this model from previous models, which resulted in a “closed” elevator channel rather than an “open” elevator channel, were significant and impacted the safe use of the device.  
  
FDA spokeswoman **Deborah Kotz** told Petersen that the agency was “was aware of these reports and continues to investigate adverse events associated with duodenoscopes as appropriate.”