—#190170

Product

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V

FDA product code: FDT — Duodenoscope And Accessories, Flexible/Rigid
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K143153
Affected lot / code info: All serial numbers. UDI: 04953170339967

Why it was recalled

Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Olympus issued Urgent Medical Device Corrective Action on 11/02/21. Letter states reason for correction, health risk and action to take: 1. Consider transitioning from TJF-Q180V to a next generation duodenoscope through the Olympus incentive program. 2. Increase preventative maintenance frequency from annual to 6 months. 3. Evaluate existing duodenoscopes: https://medical.olympusamerica.com/TJFQ180VChecklist 4. The Technical Assistance Center (TAC) can assist you in answering questions on the TJF-Q180V inspection steps. 1-800-848-9024, option 1. 5. Use in-service training, the Olympus Video Guide, e-learning and on demand library to support staff training. ***UPDATE: Olympus issued an Urgent Medical Device Corrective Action UPDATED INFORMATION on 1/17/22. This is an update to the 11/2/21 previously provided supplemental material for inspection. In alignment with FDA Safety Communication dated August 29, 2019, and to further expedite transition to newer-generation duodenoscopes, Olympus America will soon begin offering customers with the older generation TJF-Q180V2 scopes a direct, no-cost 1 for 1 replacement with the state-of-the-art TJF-Q190V. Your Olympus sales representative will contact you regarding this program in the near future. In the interim, please continue to utilize the TJF-Q180V Inspection Checklist that Olympus recently sent. Olympus America will also be increasing the frequency of proactive inspection from once every twelve (12) months to once every six (6) months. To help minimize any potential patient impact regarding access to critical, life-saving ERCP procedures, loaners are available to mitigate disruption to healthcare facilities who need to return their duodenoscope(s) to Olympus for repair. For any questions or concerns, please do not hesitate to contact me directly at Cynthia.Ow@Olympus.com.

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: 2021-11-02
Posted by FDA: 2021-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190170. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.