Recall Z-0757-2016 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
| Date | Feb 4, 2016 (initiated Jan 8, 2016) |
| Status | Terminated |
| Reason | Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared TJF-Q180V 510k. |
| Root cause | No Marketing Application |
| Action | Olympus America Inc. sent an Urgent Notification letter dated January 15, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory for the affected product, Olympus will contact facilities to make arrangements for return of the TJF-Q180V duodenoscope(s) for the elevator mechanism replacement. For questions call (484) 896-5688. |
| Quantity | 4436 |
| Distribution | US Nationwide Distribution except PR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080403 | XTJF TYPE Q160VF1 Olympus Medical Systems Corporation, May 20, 2008 |