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Olympus recallZ-1815-2022 · Olympus Corporation of the Americas · initiated Aug 12, 2022

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

An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

FDA root cause category: Under Investigation by firm

What the company is doing

Olympus issued Urgent Medical Device Recall Letter on 8/12/22 to Surgical Department Risk Management. Letter states reason for recall, health risk and action to take: 1. Immediately locate any product with affected lot numbers listed in this communication. See Attachment 2 for pictures showing the location of lot numbers on the package. 2. Call your Olympus customer service representative at 1 800 848 9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility upon return of affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number 0412 and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please notify your customers of this removal action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Contact directly at (647) 999-3203 or at [email protected] for any additional information or support concerning this matter.

Recall details

Recall number
Z-1815-2022
Status
Open, Classified
Initiated by the company
Aug 12, 2022
Posted by the FDA
Sep 26, 2022
Recalling firm
Olympus Corporation of the Americas
Quantity
44 units (5/box); 133 units (5/box) OUS
Product code
GEI
FDA submissions
K212643
Distribution
Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA

Product description

Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.

Code information (models, lots, serial numbers)

UDI-DI: 00821925044579 Lot Numbers: CA191182 CA191183 CA191184 CA191185 CA191186 CA236235 CA236237 FR230559

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

2 devices cleared under K212643 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 90788).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page