Recall Z-2519-2018 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
Uretero-reno fiberscope URF-P6
| Date | Jan 17, 2018 |
| Status | Terminated |
| Reason | Breakage of the endoscope's insertion tube bending section during surgical procedures. |
| Root cause | Device Design |
| Action | On 1/17/18 an Urgent Medical Device Removal Action Notification letter was shipped to affected customer via Fed-EX. The notification informed customers the recall was initiated in response to customer complaints regarding the breakage of the endoscopes insertion tube bending section during surgical procedures.Customers were instructed to complete the following: 1. Inspect your inventory and identify any URF-P6/P6R models; 2.Olympus will contact your facility to make arrangements for return of your URF-P6/P6R fiberscope(s) for the device exchange. You will be provided instructions on returning |
| Quantity | 1062 |
| Distribution | US Nationwide. Canada and Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172298 | OLYMPUS URF-P6/P6R Olympus Medical Systems Corp., Mar 29, 2018 |