A series of Olympus bronchofiberscopes and bronchovideoscopes have been recalled by the manufacturer because of a risk for burns and fire, according to a statement from the US Food and Drug Administration (FDA).
However, "this recall is a correction, not a product removal," according to the FDA. Clinicians do not need to cease using these devices, but they must be mindful of the risks and take the precautions outlined by Olympus.
"While health care providers may choose to continue using the Olympus bronchofiberscopes and bronchovideoscopes, to maximize patient safety and mitigate any potential risk to patient health, the FDA and Olympus advise users not to perform high-frequency cauterization while supplying oxygen, and carefully follow the warnings provided in the Olympus operators manual and highlighted in its October 12, 2023, letter to customers," an FDA spokesperson said.
The recall affects Olympus bronchofiberscopes and bronchovideoscopes distributed between January 1, 2001, and September 11, 2023. According to the FDA statement, use of these devices may cause serious adverse events to patients and to clinicians. Patients treated with these devices could experience critical burns in the airways or lungs, airway bleeding, breathing difficulty, apnea, loss of consciousness, or death. Healthcare workers using the devices also may be affected in the event of combustion.
On October 12, 2023, Olympus sent an Urgent Medical Device Corrective Action letter. This letter outlined the risks associated with the devices as follows:
"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."
To mitigate this risk, Olympus reminds clinicians to heed the warnings found in the device operations manuals, notably these three:
- Do not perform high-frequency cauterization while supplying oxygen.
- Confirm that the electrode section of the electrosurgical device used with the endoscope is at a safe distance from the distal end of the endoscope.
- Only use the Olympus bronchoscopes with compatible high-frequency therapy equipment as described in the operations manual.
The letter also asks facilities that have purchased any of the affected bronchoscopes to ensure that all personnel are "completely knowledgeable and thoroughly aware" of the warnings stated in the operations manual, and it states that users may continue to use the devices according to the current instructions and with attention to the warnings.
Olympus Explains
"Olympus Corporation initiated this Field Corrective Action (FCA) to address complaints of endobronchial combustion occurring when high-frequency-compatible bronchoscopes are used during therapeutic procedures in combination with high-frequency therapy equipment," a spokeswoman for Olympus said in an interview.
"This corrective action was taken following a thorough assessment of adverse event complaints involving serious patient injury; Olympus takes these complaints very seriously. Patient safety is our top priority," the spokeswoman said. "The customer notification is intended to remind users of existing warnings not to use oxygen while performing high-frequency cauterization and appropriate distance while using high-frequency therapy equipment."
The products are not being removed, and no labeling changes are being made at this time, she said.
The bottom line for clinicians: "Users can continue to use Olympus bronchoscopes according to the instructions provided in the operation manual and the customer letter," the Olympus spokeswoman told Medscape Medical News. "This is not a removal action. There are no changes to the existing operation manual regarding compatibility of bronchoscopes with high-frequency therapy equipment," she said.
"In terms of actions going forward, in addition to the communication provided through this Field Corrective Action, which is intended to remind users of recommendations on oxygen use and clarify the appropriate distance while using high-frequency therapy equipment, the root cause and potential contributing factors are currently under investigation through a formal CAPA (Corrective Action Preventative Action) process. Olympus will take any appropriate enhancement action based on investigation results," according to the Olympus spokeswoman.
In 2016, Medscape Medical News reported that Olympus made medical headlines by recalling its TJF-Q180V duodenoscope in the wake of Congressional investigations after the product was linked to spreading bacterial infections because of design flaws.
United States customers can contact Olympus by phone at 1-800-848-9024 (option 1) with questions about the recall, and healthcare professionals and consumers may report adverse reactions or quality problems associated with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program via an online form, regular mail, or fax.