Class 2 Device Recall Pentax

• Date Initiated by Firm: April 21, 2021
• Create Date: May 25, 2021
• Recall Status: Terminated on February 05, 2024
• Recall Number: Z-1682-2021
• Recall Event ID: 87763
• 510(K)Number: K192245 K210710
• Product Classification: Duodenoscope and accessories, flexible/rigid - Product Code FDT
• Product: Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.
• Code Information: All units
• Recalling Firm/ Manufacturer: Pentax of America Inc; 3 Paragon Dr; Montvale NJ 07645-1782
• For Additional Information Contact: SAME; 973-628-2199
• Manufacturer Reason for Recall: IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure and updated to notify users of what immediate actions should be taken in case the event occurs. This can result in unforseen events such as mucosal injury, lacerations, or bleeding of the patient. Detachment of the distal end cap (OE-A63) into the oral cavity of the patient may also result in aspiration
• FDA Determined Cause: Process design
• Action: Pentax issued Urgent Medical Device Correction letter on 4/21/21 via USPS. Letter states reason for recall,health risk and action to take: We have updated our instructions for use (IFU) for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope. The warning section of the IFU has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure. In addition, the IFU has been updated to notify users of what immediate actions should be taken in case the event occurs. Please note that this documentation set is current as of this date. For updates, please refer to the PENTAX online IFU library at https://ifu.pentaxmedical.com. Customer Instructions: Please complete the enclosed Field Correction Response Form upon receipt of this package, and email to PENTAX at customeradvisories@pentaxmedical.com. Adverse events experienced with the use of this product should be reported as soon as possible to PENTAX at vigilance@pentaxmedical.com. PENTAX will issue additional communications as further information becomes available. If you have any questions regarding this action, please feel free to contact us at: : Tel: 1-800-431-5880 (8:30 AM  5:00 PM, Monday  Friday, EST) Fax: 201-799-4063 (alternate 201-391-4189) Email: customeradvisories@pentaxmedical.com
• Quantity in Commerce: 108 units
• Distribution: US Nationwide distribution in the states of Alabama, California, Louisiana, Maryland, Michigan, Missouri, New Jersey, North Carolina, Pennsylvania, Texas, Washington, D.C.
• 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 = FDT and Original Applicant = PENTAX of America, Inc.