Olympus Corporation of the Americas Recalls Laser-Compatible Olympus Bronchoscopes for Risk of Endobronchial Combustion and Patient Burns
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.
Recalled Product
- Product Names and Model Numbers: Certain Olympus bronchofiberscopes and bronchovideoscopes. See below for full list.
- Serial Numbers: All
- Distribution Dates: January 20, 1999 to May 3, 2023
- Devices Recalled in the U.S.: 15,586
- Date Initiated by Firm: June 8, 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 is recalling laser-compatible bronchoscopes after reports of burns occurring inside the airways and lungs due to endobronchial combustion (airway fire) during therapeutic procedures that used both the bronchoscope and laser therapy equipment or argon plasma coagulation.
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, anoxic encephalopathy (brain injury due to lack of oxygen), or death. Injuries may lead to prolonged procedures, additional medical care, extended hospitalization, ICU care, and death.
Olympus Corporation of the Americas has reported three patient injuries including one patient death related to this issue .
Who May be Affected
- People who receive care using Olympus laser-compatible bronchoscopes.
- Health care providers who use Olympus laser-compatible bronchoscopes to care for patients.
What to Do
On June 8, 2023, Olympus Corporation of the Americas sent affected customers an Urgent Medical Device Corrective Action letter with the following recommended actions:
Actions to be taken by users
- Inspect inventory for referenced devices and identify any device with the model names.
- Check all areas of the hospital to determine if any of these devices remain in inventory.
- Carefully read the content of the corrective action letter as well as the attached addendum, which includes compatible laser types.
- Make sure 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.
- Do not use supplemental oxygen during laser bronchoscopy procedures.
- Ensure the distance between the bronchoscope tip and laser energy source is adequate, per the Instructions for Use.
- Acknowledge receipt of the corrective action letter through the Olympus recall portal at https://olympusamerica.com/recall.
- Enter the file (recall) number: 0427
- If this product was further distributed, identify customers, forward them the notification, and appropriately document the notification process.
Actions to be taken by the company
Labeling for these devices will be updated to include:
- Specificity about laser compatibility
- Improved instructions regarding patient preparation
- Warnings about patient injury and death resulting from incompatible laser use
Contact Information
Customers with questions about this recall should call (647) 999-3203 or email Cynthia.Ow@Olympus.com.
Full List of Affected Devices
| Olympus Bronchoscope BF Type | Models |
|---|---|
| Bronchofiberscope | BF-PE2, BF-TE2 |
| OES Bronchofiberscope | BF-P60, BF-1T60, BF-MP60, BF-XT40 |
| 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, BF-Q180 |
| Evis Exera III Bronchovideoscope | BF-1TH190, BF-H190, BF-Q190, BF-XT190 |
Additional Resources
- Medical Device Recall Database Entries
- Firm Press Release: Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment
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 the online form or call 1-800-332-1088 for more information on how to mail or fax the form.