One of the three Japan-made endoscopes associated with recent "superbug" outbreaks--the duodenoscope made by Olympus--did not have FDA approval, CNN reports. But Olympus said the report was based on a modification it made that didn't require FDA approval.
Problems with Olympus, Fujifilm Holdings and Pentax duodenoscopes surfaced after an outbreak of 179 cases of "superbug" in a Los Angeles hospital was blamed for two deaths. Since then, similar cases have been reported at several other hospitals around the country. The "superbug" apparently developed because of problems with cleaning and disinfecting the scopes after each use.
CNN cited an FDA official who said the agency noticed only within the past two years that Olympus had never filed for approval of its TFJ-Q18OV duodenoscope, which was launched on the U.S. market in 2010.
Olympus responded that FDA policy does not require a new application for a modification such as the one it made to a previously approved device. CNN later reported that after spotting its alleged oversight, the FDA requested that Olympus apply for approval of the modified device last year. The company subsequently filed, and its application is under review.
Ironically, Olympus had modified its device to seal up a part that failed to get disinfected properly, the agency official told CNN.
- here's the story from CNN
- here's the Olympus release