Category: 510(k) Clearances

The Redesigned Olympus Duodenoscope Has Been Linked to a ‘Superbug’ Cluster The device's original design was recalled in January 2016 amid concerns about its safety.

March 21, 2017 (9:58 pm ET) — A “corrected” duodenoscope design introduced last year by the manufacturer to replace a recalled device has been linked to a “superbug” cluster, I have learned. The…

USA TODAY Investigation: “Reports to Feds on deadly bacteria outbreaks arrived late”

Medical device reports — or, MDRs, which manufacturers of duodenoscopes and other medical devices are required to submit to the FDA within 30 days of learning that their device might…