Device product
Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Z-2066-2016
Product summary
- Event
- Event 73894
- Status
- Terminated
- Classification
- Class II
- Quantity
- 126 units
- Official record key
device-enforcement:Z-2066-2016
Official wording
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.
Code information: Model #'s ECN-1530 and FCN-15X
Distribution pattern: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Derived failure modes
-
Unknown
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.