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Olympus recallZ-2541-2024 · Olympus Corporation of the Americas · initiated Jul 1, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Package design/selection

What the company is doing

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 [email protected]

Recall details

Recall number
Z-2541-2024
Status
Open, Classified
Initiated by the company
Jul 1, 2024
Posted by the FDA
Aug 8, 2024
Recalling firm
Olympus Corporation of the Americas
Quantity
6985 units
Product code
GEI
FDA submissions
K023492
Distribution
Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.

Product description

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.

Code information (models, lots, serial numbers)

UDI: 00821925035881 Batch Number: FR137723 FR139935 FR141534 FR145203 FR157420 FR165250 FR176934 FR179541 FR197926 FR204443 FR206007 FR207123 FR214689 FR215012 FR215026 FR246906 FR261731 FR297010 FR305512 FR308131 FR335638 FR335650 FR378737 FR390629 FR397748 PW308683

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K023492 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94953).

Sources and updates

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