Recalls / —

—#202210

Product

EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

FDA product code

FDT — Duodenoscope And Accessories, Flexible/Rigid

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K193182, K202661, K220587

Affected lot / code info

Model No. TJF-Q190V; UDI-DI: 04953170405563; All Serial No.

Why it was recalled

Recent reports of patient infection.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Consignees were sent an Urgent Medical Corrective Action notification dated 7/27/2023. This action is being initiated due to the firm becoming aware of and FDA inquiring about recent reports of infections and positive cultures. Olympus is reminding users to closely follow reprocessing instructions, including periodic inspections by Olympus Service, and informing users about an updated manual intended to improve comprehension of existing reprocessing steps. Additional enhancements to the manual include the use of reprocessing timelines and simplified text/visualization techniques. The manual is available on the customer web portal and paper copies, along with wall charts, are available to be mailed to your facility. The notification also emphasises the required inspection of the forceps elevator mechanism, to be performed once a year or every 100 reprocessing cycles, and encourages consignees to consider incorporating voluntary routine microbiologic surveillance of endoscops as part of their quality improvement/assurance efforts. Consignees are asked to complete and return the provided response form to Sedgwick via email at ollympus7521@sedgwick.com or by fax to 888-208-4588. Questions can be directed by phone to 866-912-9552. Customers can also contact Ashley Mitch at Olympus by phone at 484-553-1029 or by email at Ashley.Mitch@olympus.com with any additional concerns.

Recalling firm

Firm

Olympus Corporation of the Americas

Address

3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern

US Nationwide distribution.

Timeline

Recall initiated

2023-07-27

Posted by FDA

2023-08-28

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #202210. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.