Class 2 Device Recall Quick Clip Pro

• Date Initiated by Firm: May 04, 2023
• Date Posted: June 21, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1989-2023
• Recall Event ID: 92325
• 510(K)Number: K123601
• Product Classification: Hemostatic metal clip for the GI tract - Product Code PKL
• Product: Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
• Code Information: UDI-DI: 04953170385933 Lot Numbers: 24K, 25K, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: SAME; 484-896-5000
• Manufacturer Reason for Recall: Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
• FDA Determined Cause: Under Investigation by firm
• Action: Olympus issued Urgent Medical Device Recall Letter dated 5/4/23. Letter states reason for recall, health risk and action to take: 1. Immediately assess any product you have to identify HX-202LR/UR with affected lot number listed in this communication, cease use of product and quarantine any affected product. The images in Attachment 1 depict the area where the lot number is identified. The lot# is on the carton box, pack and handle. 2. Contact our Olympus Customer Service Team at 1-800-848-9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility upon return of affected product. 3. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the recall number: 0424 c. Complete the form as instructed. 4. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Contact (647) 999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.
• Quantity in Commerce: 13707 pieces
• Distribution: US 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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