Recall Z-0379-2022 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
| Date | Dec 10, 2021 (initiated Nov 2, 2021) |
| Status | Open, Classified |
| Reason | 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 | Under Investigation by firm |
| Action | 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 Olym |
| Quantity | 14,447 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143153 | EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V Olympus Medical Systems Corp., Jan 15, 2016 |