Recall Z-1548-2024 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Olympus Corporation of the Americas
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-645L
| Date | Sep 12, 2024 (initiated Mar 1, 2024) |
| Status | Open, Classified |
| Reason | Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury |
| Root cause | Use error |
| Action | Olympus Corporation of the Americas issued Medical Device Safety Reminder letter on 3/1/24 via UPS. Letter states reason for recall, health risk and action to take: 1. Follow your facility's procedures for communication and handling of Field Safety Notices. Ensure all personnel, including clinical staff, are informed of the contents of this letter and the Instructions for Use. You may add a copy of this letter with your IFU. 2. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall. b. Enter the recall number: 0443 c. |
| Quantity | 2525 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182408 | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 Olympus Medical Systems Corp., May 15, 2019 |