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Olympus recallZ-1700-2024 · Olympus Corporation of the Americas · initiated Mar 7, 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

Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.

FDA root cause category: Process control

What the company is doing

Olympus issued Urgent Medical Device Removal Letter on April 2, 2024 via email/visit. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory and identify any POWERSEAL products having the lot number identified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lots. 2. Please contact Customer Service at at 1-800-848-9024, option 2, with the quantity, model and lot number of the affected device(s). Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of the affected product. 3. 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 "0444 . c. Complete the form as instructed and include your account ID number. 4. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. 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-1700-2024
Status
Open, Classified
Initiated by the company
Mar 7, 2024
Posted by the FDA
Apr 30, 2024
Recalling firm
Olympus Corporation of the Americas
Quantity
850 units: (400 units US);(450 units OUS)
Product code
GEI
FDA submissions
K212643
Distribution
Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.

Product description

POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA

Code information (models, lots, serial numbers)

UDI-DI: 00821925044555 Lot numbers: CA182543, CA182544, CA182546, CA182548, CA191230

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 94375).

Sources and updates

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