Recall Z-2067-2016 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
Pentax Medical Company
Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct when indications consistent with the need
| Date | Jun 28, 2016 (initiated Apr 6, 2016) |
| Status | Terminated |
| Reason | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
| Root cause | Device Design |
| Action | Pentax sent an Urgent Field Correction letter dated April 6, 2016 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were reminded to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices passed through the instrument channel are accounted for after use. If the instrument/suction channel does become blocked or clogged due to the accumulation of debris, an accessory that cannot |
| Quantity | 50 units |
| Distribution | Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953286 | FCP-9P, FIBER CHOLEDOCHOSCOPE Pentax Precision Instrument Corp., Nov 3, 1995 |