Recalls / —

—#200492

Product

Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150

FDA product code

EOQ — Bronchoscope (Flexible Or Rigid)

Device class

Class 2

Medical specialty

Ear, Nose, Throat

510(k) numbers

K023984

Affected lot / code info

All serial numbers BF-P150* BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150 UDI: 04953170288876 BF-1T150 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150 UDI: 04953170288968

Why it was recalled

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An "URGENT MEDICAL DEVICE CORRECTIVE ACTION" notification letter dated 6/8/23 was sent to customers. Actions to be taken by the company: The labelling will be updated to include specificity about laser compatibility, improved instructions regarding patient preparation, and warnings about patient injury and death resulting from incompatible laser use. Actions to be taken by the end user: 1. Inspect your inventory for the referenced devices and identify any device with the model names. Please check all areas of the hospital to determine if any of these devices remain in inventory. 2. Carefully read the content of this Medical Device Correction Action as well as the attached Addendum . The addendum provides compatible laser type. 3. Ensure all personnel are completely knowledgeable and thoroughly aware that Olympus laser compatible bronchoscopes are compatible only with Nd: YAG laser or 810 nm diode lasers. 4. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the file (recall) number: 0427 5. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. Olympus requests that you report complaints, including any injuries associated with laser procedures with Olympus bronchoscopes, to our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Olympus regrets any inconvenience caused and fully appreciates your cooperation in this matter. Please do not hesitate to call (647) 999-3203 or email: at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.

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

2023-06-08

Posted by FDA

2023-07-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #200492. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.