Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A

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.

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 [email protected] for any additional information or support concerning this matter.