ESG PK CUTTING FORCEPS, 5MM, 33CM

FDA device recall Z-1167-2024 · posted 2024-02-20 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.

Action taken

On January 15, 2024, the firm notified customers of the issue via URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect your inventory and identify any products of the model and lots subject to this action. 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. Customers were given detailed instructions on how to identify affected product. Please contact your Olympus customer service representative 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. Customers who have further distributed product should notify downstream accounts at once. If you require assistance with identifying affected product, please contact the Olympus Technical Assistance Center at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. If you have questions about this recall, please contact the recalling firm at (647) 999-3203 or by e-mail at Cynthia.Ow@Olympus.com.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GEI

Quantity affected

11,123 units

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Mexico, P.R. China, Singapore, South Korea.

Date initiated

2023-12-15

Date posted

2024-02-20

Location

Center Valley, PA

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