Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue

FDA device recall Z-1548-2024 · posted 2024-09-12 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

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

Action taken

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.

Root cause

Use error

Status

Open, Classified

Product code

KNS

Quantity affected

2525 units

Distribution

Nationwide

Date initiated

2024-03-01

Date posted

2024-09-12

Location

Center Valley, PA

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