UPDATE: Dec. 21, 2023: Olympus Corporation’s recall of bronchofiberscopes and bronchovideoscopes has been associated with 192 complaints, including four injuries, according to a recall notice posted Tuesday by the Food and Drug Administration.
“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,” the FDA stated in the notice. The agency added injuries may lead to longer procedures, additional care, extended hospital stays, ICU care and death, though no deaths have been reported.
Device combustion can also cause damaged or broken parts to injure or remain inside patients, which may require surgery to remove them.
The FDA posted the recall in a database in early November but waited to publish the recall notice until this week. The recall impacts 17,691 devices in the U.S. distributed between Jan. 1, 2001, and Sept. 11, 2023, according to the notice. No devices need to be removed.
Dive Brief:
- Olympus Corporation has issued another corrective action for numerous models of bronchoscopes after reports of injuries where patients may have suffered burns to their airways or lungs.
- The corrective action came after four adverse event reports of “endobronchial combustion during therapeutic procedures with Olympus bronchoscopes,” an Olympus spokesperson said in an emailed statement.
- The Food and Drug Administration labeled the corrective action as a Class I recall, though Olympus said in a Nov. 9 press release that no devices need to be removed. The recall affects nearly 68,000 devices according to an FDA report entry.
Dive Insight:
Bronchoscopes are used for endoscopic diagnosis and treatment in the airways to the lungs. In an Oct. 12 letter to customers, Olympus warned healthcare personnel about the risks of conducting high-frequency cauterization with Olympus bronchoscopes in an oxygenated environment, which may result in combustion during cauterization.
The company said in a press release that it “assessed the issue after receiving complaints of adverse events involving serious patient injury, where patients may suffer burns to the airway or lungs that may result in the need for additional medical intervention, prolonged procedure times, extended hospitalization, ICU care, and death.”
Twenty-eight BF series endoscope models globally are affected by the action, including 15 models distributed in the U.S. The Olympus spokesperson said one injury report involved high-frequency therapy equipment, while three involved unknown energy therapy equipment.
In July, the company announced a separate corrective action after reports of endobronchial combustion for bronchoscopes used with laser therapy equipment. Olympus determined that labels would need to be updated after reports of patients suffering serious injury and one death.
The bronchoscope recalls add to several safety problems at the company. Olympus also issued a recall last month for abdominal insufflation devices that were linked to reports of 21 device malfunctions, 10 serious injuries and one patient death. The FDA said the devices were recalled because they could over-inflate air into the body with no warning or alarm.
Additionally, the FDA’s Center for Devices and Radiological Health Director Jeff Shuren accused Olympus of “troubling disregard for patient safety” after sending the company a warning letter in March. The letter followed an inspection of a facility in Tokyo in November 2022. The FDA also sent warning letters to the company and its subsidiary Aizu Olympus late last year regarding violations of medical device reporting requirements and safety issues related to cleaning and disinfecting endoscopes for reuse.
