Recall Z-1010-2019 ยท NWB Endoscope, Accessories, Narrow Band Spectrum
Olympus Corporation of the Americas
Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
| Date | Dec 17, 2018 |
| Status | Terminated |
| Reason | The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair. |
| Root cause | Under Investigation by firm |
| Action | Customers were contacted via telephone on 12/17/18. Customers were also sent notification letters on 1/2/19. |
| Quantity | 2 |
| Distribution | US Nationwide distribution in the states of CT, IL, MN, MO, and NC. |
| 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 |