—#207909

Product

OES 4000 Hysteroscope, Model/Catalog Number: A4674A

FDA product code: HIH — Hysteroscope (And Accessories)
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K897003
Affected lot / code info: Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;

Why it was recalled

The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.

Root cause (FDA determination)

Process change control

Action the firm took

On May 9, 2024, URGENT: MEDICAL DEVICE REMOVAL letters were sent to the consignee. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Examine your inventory and identify the above listed device with serial number. 3. Please contact Customer Service at at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus, and we will replace this device at no charge. 4. Olympus requests that you acknowledge receipt of this letter through the a. Go to https://olympusamerica.com/recall b. Enter the recall number "XXXX . c. Complete the form as instructed and include your account ID number: XXXXXXXX 5. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including foggy image, to the Technical Assistance Center (TAC) 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. Olympus fully appreciates your prompt cooperation in addressing this situation. 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: US Nationwide distribution in the state of NY.

Timeline

Recall initiated: 2024-04-18
Posted by FDA: 2024-06-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207909. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.