—#206517

Product

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

FDA product code: KNS — Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K182408
Affected lot / code info: UDI-DI: - 04953170407857 All lots numbers

Why it was recalled

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 (FDA determination)

Use error

Action the firm took

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. Complete the form as instructed. 3. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. Olympus requests you to report any complaints, including any injuries associated with Triangle Tip Electrosurgical knife tip breakage, the Olympus Technical Assistance Center at 1-800-848-9024, option 1. If you require additional information, please do not hesitate to contact me directly at 647-999-3203 or Cynthia.Ow@Olympus.com.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2024-03-01
Posted by FDA: 2024-09-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206517. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.