Recall Z-0638-2022 ยท FEB Accessories, Cleaning, For Endoscope
Olympus Corporation of the Americas
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
| Date | Dec 13, 2021 |
| Status | Terminated |
| Reason | The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent |
| Root cause | Process control |
| Action | Olympus issued Urgent Medical Device Correction letter dated 12/13/21. Letter states reason for recall, health risk and action to take: 1. Please immediately perform an inspection of your installed OER-Elite units as described in the Attachment 1 Alcohol Rinse Inspection . If you require assistance, please contact your local Endoscopy Support Specialist (ESS). 2. If the inspection check does not pass, stop using the OER-Elite and endoscopes reprocessed with that OER-Elite. Contact Olympus TAC at 1-800-848-9024, option 1 for further instruction. If the inspection check passes, you may continue |
| Quantity | 295 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |