Recalls / —

—#202564

Product

Olympus Bronchovideoscope, Models BF-3C160.

FDA product code

EOQ — Bronchoscope (Flexible Or Rigid)

Device class

Class 2

Medical specialty

Ear, Nose, Throat

510(k) numbers

K963033

Affected lot / code info

UDI-DI: 04953170340031 & 04953170063039; All Serial Numbers.

Why it was recalled

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Consignees were mailed an Urgent Medical Device Correction notification dated 7/27/2023 via UPS. The notification asks that consignees inspect their inventory for recalled devices and check clinical areas to see if any remain in use. Consignees are to ensure that all personnel, including clinical staff, are completely knowledgeable of this recall notification and addendum, which instructs users to slide the endotracheal tube along the entire length of the tracheal intubation scope insertion section to confirm compatibility before using on a patient. Consignees are asked to complete and return the provided response form to Sedgwick via email at Olympus7498@sedgwick.com or by fax at 866-552-4917. Any questions about the acknowledgement form may be directed by phone to 866-737-4762. If product has been further distributed, please forward the notification to those secondary consignees and maintain records of your documentation process. Consignees are to report any complaints to Olympus Technical Assistance Center at 1-800-848-9024 (Option 1) and FDA Medwatch. Any further questions are to be directed to Tara Safi by email at Tara.Safi@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.

Timeline

Recall initiated

2023-07-27

Posted by FDA

2023-08-31

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #202564. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.