The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ou

FDA device recall Z-2542-2024 · posted 2024-08-08 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

Action taken

Olympus issued Urgent Medical Device Removal letter on July 1, 2024. Letter states reason for recall, health risk and action to take: 1. Carefully read the content of this notification. 2. Examine your inventory and identify the above listed device(s) with the affected batch number. 3. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus. When it is received, you will receive a credit for your affected device(s). 4. Olympus requests that you acknowledge receipt of this letter. 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 "0449 c. Complete the form as instructed and include your account ID number. 5. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including package damage or signs of sterility breach, to the Technical Assistance Center (TAC) at 1- 800-848-9024, option 1. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@Olympus.com

Root cause

Package design/selection

Status

Open, Classified

Product code

GEI

Quantity affected

4364 units

Distribution

Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.

Date initiated

2024-07-01

Date posted

2024-08-08

Location

Center Valley, PA

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