Recall Z-2807-2015 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Olympus America Inc.
EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
| Date | Sep 22, 2015 (initiated Mar 26, 2015) |
| Status | Terminated |
| Reason | New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures. |
| Root cause | Labeling design |
| Action | The firm, Olympus, sent an "Urgent Safety Notification" dated March 26, 2015, to direct consignees/customers. The notification described the product, problem and actions to be taken. The notification contained new reprocessing procedures. The customers were instructed to immediately implement new precleaning and high level disinfection procedure; ensure that all personnel involved in the reprocessing are completely knowledgeable and thoroughly trained on the new reprocessing instructions; complete and return the enclosed questionnaire via fax to (484) 896-7128 and implement the new cleaning in |
| Quantity | 6109 |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080403 | XTJF TYPE Q160VF1 Olympus Medical Systems Corporation, May 20, 2008 |