Duodenoscope Model TJF-Q180V by Olympus: UPDATED FDA Safety Communication - New Reprocessing Instructions Validated
UPDATED 01/15/2016. The Agency is redistributing the March 26, 2015 Safety Communication with updated status information about the Agency's 510(k) clearance decision and Olympus Corporation of the America's Customer Notification.
On March 4, 2015, the FDA provided Updated Information for Health care Providers Regarding Duodenoscopes. At that time, Olympus had a pending 510(k) application for its TJF-Q180V duodenoscope. The company continued to market this device while its application was under review. On January 15, 2016, the FDA cleared the TJF-Q180V duodenoscope 510(k) with design modifications to the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel.
Also on January 15, 2016, Olympus notified its customers by issuing a Customer Notification Letter 
that:
that:- Includes information about the TJF-Q180V duodenoscope’s design and labeling changes per the cleared 510(k);
- Outlines Olympus’ strategy to repair all customers’ TJF-Q180V elevator mechanism in accordance with the new design; and
- Informs customers that Olympus will set up a return schedule with them for duodenoscope repair.
The validated manual reprocessing procedures outlined in the March 26, 2015 Safety Communication ‘Validated Manual Reprocessing Procedure' section remain the same. Health care facilities should continue to use these validated instructions when reprocessing Olympus TJF-Q180V duodenoscopes.
Read the UPDATED MedWatch safety alert at:
.png)
No hay comentarios:
Publicar un comentario