Recall Z-1988-2023 ยท PKL Hemostatic Metal Clip For The Gi Tract
Olympus Corporation of the Americas
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
| Date | Jun 21, 2023 (initiated May 4, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 c |
| Quantity | 45 pieces |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123601 | SINGLE USE REPOSITIONABLE CLIP Olympus Medical Systems Corp., Apr 29, 2013 |