—#208931

Product

The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of compatible generators. The forceps' jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. To transect tissue, a cutting blade is actuated and moves between the electrode jaws. The connections (bipolar electrical signal) to the forceps are through either a hardwired cable (model 3006) or a connector at the bottom of the handle (models 3000 and 3005). The device includes mechanisms (switches and triggers) to provide coagulation using the bipolar electrical energy that reaches the forceps. The forceps are positioned in the desired location for grasping, coagulation, and transection of tissue. The anatomical structure to be coagulated is placed between the open forceps jaws, and once the Forceps Grip trigger is squeezed, the forceps' jaws are closed onto tissue, followed by coagulation. The device includes a blade that is mechanically advanced to perform tissue cutting as needed.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K023492
Affected lot / code info: UDI: 00821925035898 Batch Number: FR145210 FR150478 FR163740 FR165213 FR177466 FR179534 FR179557 FR188129 FR200177 FR215047 FR220528 FR220979 FR224466 FR234887 FR248322 FR253501 FR255664 FR263141 FR269277 FR276180 FR287091 FR303624 FR305537 FR316877 FR378738 FR388883 PW308633 PW308686 PW308722 PW308723

Why it was recalled

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

Root cause (FDA determination)

Package design/selection

Action the firm took

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

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2024-07-01
Posted by FDA: 2024-08-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208931. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.