Olympus' TJF-Q180V duodenoscope that includes modifications to the device design and labeling has received FDA 510(k) clearance.
Here are eight key notes:
1. Beginning in early February, Olympus will implement a corrective action in the United States for current TJF-Q180V duodenoscopes.
2. These changes involve new parameters that were reviewed by FDA prior to the 510(k) clearance.
3. The changes include replacing the forceps elevator mechanism with a new design.
4. Detailed instructions about how to complete this process will be sent to customers.
5. Additionally, the corrective action includes an updated Operation Manual and Reprocessing Manual for the TJF-Q180V.
6. Last year in March, Olympus was slammed with lawsuits from five patients who were infected with carbapenem-resistant Enterobacteriaceae after undergoing ERCP at UCLA Ronald Reagan Medical Center in Los Angeles.
7. The TJF-Q180V duodenoscope did not have FDA 510(k) clearance last March.
8. Other duodenoscope manufacturers were also linked to superbug infections at several medical centers last year. A recent Senate health committee report found that the duodenoscope has caused more superbug infections than earlier reported, revealing 25 antibiotic-resistant infections at 19 U.S. hospitals and six European hospitals.