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  5. Olympus Corporation of the Americas Recalls Bronchofiberscopes and Bronchovideoscopes Because They Can Lead to Burns and Fire
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Olympus Corporation of the Americas Recalls Bronchofiberscopes and Bronchovideoscopes Because They Can Lead to Burns and Fire

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Please be aware, this recall is a correction, not a product removal.

This recall is an expansion of an earlier recall. The recalling firm has identified additional devices and corrective actions for users to take.

Recalled Product

  • Product Names and Model Numbers: Certain Olympus bronchofiberscopes bronchovideoscopes. See below for full list.
  • Serial Numbers: All
  • Distribution Dates: January 1, 2001 to September 11, 2023
  • Devices Recalled in the U.S.: 17,691
  • Date Initiated by Firm: October 12, 2023

Device Use

The bronchofiberscopes and bronchovideoscopes are tubular devices that work with accessories like cameras, lights, and instruments to examine or treat a person's airways. These devices are intended to be used for endoscopy and endoscopic surgeries.

Reason for Recall

Olympus Corporation of the Americas (Olympus) is recalling certain bronchofiberscopes and bronchovideoscopes because use of certain accessories involving use of high-frequency therapy while supplying oxygen may lead to fires and burns.

Using the affected bronchoscopes may cause serious adverse health consequences, including critical burns in a person's airways or lungs, airway bleeding, trouble breathing, apnea, loss of consciousness, or death. Injuries may lead to prolonged procedures, additional medical care, extended hospitalization, ICU care, and death. Combustion can damage or break parts of the device that may injure or unintentionally remain in the patient and may require endoscopic retrieval or surgical removal.

FDA is aware of seven medical device reports specifically reporting thermal-related injuries associated with these devices, which includes the use of lasers with these devices. These MDRs cite injuries from thermal events such as melting and fire.

In addition to the risks with the use of lasers, there is a risk of combustion if:

  • high-frequency cauterization is performed while supplying oxygen, or
  • the electrode section of an electrosurgical accessory is too close to the end of the endoscope.

Who May be Affected

  • People who receive care using Olympus bronchoscopes compatible with high-frequency therapy equipment.
  • Health care providers who use affected Olympus bronchoscopes compatible with high-frequency therapy equipment to care for patients. 

What to Do

On October 12, 2023, Olympus sent all affected customers an Urgent Medical Device Corrective Action.

The letter asked customers to review the warning section in the device's operations manual, especially:

  • Stop performing high-frequency cauterization while supplying oxygen.
  • Keep electrosurgical devices used with the endoscope far enough away from the endoscope.
  • Only use high-frequency equipment that is compatible with the Olympus bronchoscope, as listed in the operations manual.
  • Complete the response form and return to Sedgwick, via Email (Olympus4907@sedgwick.com) or Fax (866-808-1177). For any questions about the acknowledgement form, please call the Sedgwick team at 855-215-5128.
  • If this product was further distributed, identify customers, forward them this notification, and appropriately document your notification process.

Contact Information

Customers in the U.S. with questions about this recall should contact Olympus at 1-800-848-9024 (option 1).

Full List of Affected Devices

Olympus Bronchoscope BF Type Models
OES Bronchofiberscope BF-P60, BF-1T60
Bronchovideoscope BF-1T150, BF-P150, BF-Q170
Evis Exera Bronchovideoscope BF-XT160
Evis Exera II Bronchovideoscope BF-Q180-AC, BF-P180, BF-1T180, BF-1TQ180
Evis Exera III Bronchovideoscope BF-1TH190, BF-H190, BF-Q190, BF-XT190, BF-P190

Additional Resources

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

 
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