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.
Recall
- Recall Number
- Z-2066-2016
- Event Number
- 73894
- Firm
- Pentax Medical Company
- FEI Number
- 1000080301
- Product Code
- FBN
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- April 6, 2016
- Posted
- June 28, 2016
- Terminated
- December 21, 2017
- Address
- 3 Paragon Dr, Montvale, NJ, 07645-1782
Description
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.
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.
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 be removed, or other cause, do NOT attempt to correct the blockage or continue to use the endoscope. Customers were instructed to contact their local PENTAX Medical Service facility to have the endoscope repaired. Customers with questions were instructed to call 800-431-5880, ext 2064.
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
126 units