Recall Z-2467-2023 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
| Date | Aug 28, 2023 (initiated Jul 27, 2023) |
| Status | Open, Classified |
| Reason | Recent reports of patient infection. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 6,426 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |