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

FDA device recall Z-0379-2022 · posted 2021-12-10 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FDT

Quantity affected

14,447 units

Distribution

US Nationwide distribution.

Date initiated

2021-11-02

Date posted

2021-12-10

Location

Center Valley, PA

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