Class 2 Device Recall Pentax

• Date Initiated by Firm: April 06, 2016
• Date Posted: June 28, 2016
• Recall Status: Terminated on December 21, 2017
• Recall Number: Z-2066-2016
• Recall Event ID: 73894
• 510(K)Number: K951191
• Product Classification: Choledochoscope and accessories, flexible/rigid - Product Code FBN
• 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.
• Code Information: Model #'s ECN-1530 and FCN-15X
• Recalling Firm/ Manufacturer: Pentax Medical Company; 3 Paragon Dr; Montvale NJ 07645-1782
• For Additional Information Contact: Mr. Paul Silva; 800-431-5880 Ext. 2064
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 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.
• Quantity in Commerce: 126 units
• Distribution: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FBN