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EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190… recallZ-0192-2024 · Olympus Corporation of the Americas · initiated Oct 12, 2023

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

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

FDA root cause category: Under Investigation by firm

What the company is doing

An "URGENT MEDICAL DEVICE CORRECTIVE ACTION" notification letter dated 10/12/23 was sent to customers. Actions to be taken by the end user: Our records indicate that your facility has purchased one or more of the affected bronchoscopes. Olympus requests you to take the following actions: 1. Inspect your facility for the referenced devices and ensure all personnel are completely knowledgeable and thoroughly aware of the Warnings in affected bronchoscope s Operation Manual for use with High-frequency therapy equipment and that Olympus high-frequency compatible bronchoscopes are compatible only with Combination equipment list in operation manual. You may continue to use the device according to the existing instructions and warnings contained in the Instruction for Use. 2. Complete the enclosed response form and return to our recall partner, Sedgwick, via Email ([email protected]) or Fax (866-808-1177). For any questions about the acknowledgement form, please call the Sedgwick team at 855-215-5128. 3. If you have further distributed this product outside of your facility, forward them this notification and appropriately document your notification process. Olympus requests that you report to Olympus complaints, including any injuries associated with procedures involving energy devices used with Olympus bronchoscopes. Please report complaints to the Olympus 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 contact me directly at (647) 999-3203 or at [email protected] for any additional information or support concerning this matter.

Recall details

Recall number
Z-0192-2024
Status
Open, Classified
Initiated by the company
Oct 12, 2023
Posted by the FDA
Nov 9, 2023
Recalling firm
Olympus Corporation of the Americas
Quantity
32211 devices
Product code
NWB
FDA submissions
K121959
Distribution
US Nationwide distribution

Product description

EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170

Code information (models, lots, serial numbers)

Model BF-1TH190 UDI-DI: 4953170335181; Model BF-H190 UDI-DI: 4953170335174; Model BF-Q170 UDI-DI: 4953170342912 Model BF-Q190 UDI-DI: 4953170335198

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

7 devices cleared under K121959 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 93052).

Sources and updates

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