Class 2 Device Recall Pentax Inc

• Date Initiated by Firm: May 31, 2016
• Create Date: December 14, 2016
• Recall Status: Terminated on August 19, 2019
• Recall Number: Z-0757-2017
• Recall Event ID: 75249
• 510(K)Number: K131946
• Product Classification: Bronchoscope (flexible or rigid) - Product Code EOQ
• Product: Ultrasound Video Bronchoscope ; The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
• Code Information: EB-1970UK
• Recalling Firm/ Manufacturer: Pentax of America Inc; 3 Paragon Dr; Montvale NJ 07645-1782
• For Additional Information Contact: Mr. Paul Silva; 973-628-2199
• Manufacturer Reason for Recall: The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not include the cleared Operation and Reprocessing IFUs.
• FDA Determined Cause: Process control
• Action: Pentax sent a US Urgent Field Correction letter to all affected customers with a field correction/field safety response form via USPS on May 31, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Revised instructions were as follows: The instructions have been revised in the following manner: ¿ Operation IFU o Integrated all models of each family into the IFU o Modified the indications for use language to be consistent with similar products o Enhanced the explanation of the operation of the device o Revised and added cautions and warnings ¿ Reprocessing IFU o Included more specificity regarding reprocessing activities to aid in the proper method for reprocessing the endoscopes, including: ¿ number of brush and rinse steps, ¿ quantity of fluid volumes, ¿ use of additional text, figures, cautions, and warnings Identification of Affected Endoscope Models Table 1 provides an overview of the Affected Endoscope models, and the part number and revision of the historical and revised IFUs. The accompanying USB flash drive contains all the revised IFUs identified below. Please distribute only those IFUs which support the products owned by your facility. Table 1 Affected Models Historical Version of IFUs Revised IFUs EB-1970UK Ultrasound Video Bronchoscope Z870 Owners IFU S016_R02 Operator IFU S021_R04 Reprocessing IFU No.388_R01 Addendum No.392_R00 Addendum EB-70K series Video Bronchoscopes Z705 Operation IFU S015_R04 Operator IFU S020_R04 Reprocessing IFU No.388_R01 Addendum No.392_R00 Addendum Z706 Reprocessing IFU EB-75K series Video Bronchoscopes S003 Owners IFU Customers were instructed to ensure that user departments discard the prior versions of the Instructions for Use and ensure that all users read and carefully follow the revised Operation and Reprocessing IFUs to ensure the proper use and cleaning of the affected PENTAX endoscopes. Customers were advised to contact their PEN
• Quantity in Commerce: 113 units
• Distribution: Nationwide Distribution
• 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 = EOQ and Original Applicant = PENTAX MEDICAL COMPANY