A recent recall of Olympus Bronchofiberscopes and Olympus Bronchovideoscopes raises a lot of questions and concerns over whether or not the FDA is requiring enough to protect patients from potentially serious harm. October 12, 2023, Olympus Corporation of the Americas issued a voluntary recall of the Olympus Bronchofiberscopes and Olympus Bronchovideoscopes. However, the term recall is rather misleading. The product has not been recalled from use, they simply issued a recall “correction.” Medical Professionals who purchased one of their devices for use were issued a corrective letter asking users to “review the warning section in the device’s operations manual” and to take the following actions described therein:
- 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.
Why Were the Olympus Bronchofiberscopes and Olympus Bronchovideoscopes Recalled?
There have already been 192 reports of problems because when used as discouraged above, it can lead to burns or even catch fire within the patient’s airways. As a result, the uses of the product discouraged above can result in the following types of injuries:
- Serious burns to the airways
- Serious burns in the lungs
- Airway bleeding
- Trouble breathing
- Apnea
- Loss of consciousness
- Pieces of the broken/damaged scope left inside the patient
- Death
Which Olympus Bronchofiberscopes and Olympus Bronchovideoscopes are Included in the Recall?
The Olympus recall encompasses the following models sold in the United States:
- Bronchovideoscope Olympus BF Type 1T150
- Bronchovideoscope Olympus BF Type P150
- Bronchovideoscope Olympus BF-Q170
- OES Bronchofiberscope Olympus BF Type P60
- OES Bronchofiberscope Olympus BF Type 1T60
- Evis Exera Bronchovideoscope Olympus BF Type XT160
- Evis Exera II Bronchovideoscope Olympus BF Type 1TQ180
- Evis Exera II Bronchovideoscope Olympus BF Type 1T180
- Evis Exera II Bronchovideoscope Olympus BF Type P180
- Evis Exera II Bronchovideoscope Olympus BF Type Q180-AC
- Evis Exera III Bronchovideoscope Olympus BF-P190
- Evis Exera III Bronchovideoscope Olympus BF-Q190
- Evis Exera III Bronchovideoscope Olympus BF-XT190
- Evis Exera III Bronchovideoscope Olympus BF-1TH190
- Evis Exera III Bronchovideoscope Olympus BF-H190
The recall pertains to products sold in the United States from January 1, 2001, to September 11, 2023. Clearly, this is a big “recall.”
Is a Reminder a Sufficient Product Warning?
What is most concerning about this recall is that no product is being removed from the shelves. Instead, the medical professionals on record who have one are being asked to go reread the instruction manual that they were not following. The fact that there have been 192 reports of injury from people ignoring the manual makes one wonder why anyone would think asking them to reread the instruction manual would solve the issue. The letter sent by Olympus to consumers basically says to go reread this instruction and then make sure all the staff are aware of it.
The Olympus Bronchovideoscopes have been sold in the U.S. for over 22 years. Employees come and go in the healthcare industry. There is simply no way you can expect every hospital to “remember” to go over the instruction manual of every device used on the premises with every new doctor, nurse, or other professional. It seems to me that this “solution” really sets hospitals and medical professionals up for potential medical malpractice lawsuits as well as raises the question of whether a warning in this situation is or should be an adequate way to avoid a product liability lawsuit every time one of these devices is misused. If you know the warning in the manual has failed 192 times to effectively discourage serious misuse with harmful and potentially even fatal consequences, why would it be reasonable to think that reminding users to reread the failed warning would be an effective solution?
Not Olympus’ First Recall Rodeo
In July of 2023, a similar corrective recall was made by Olympus pertaining to the use of Olympus bronchoscopes warning users that their bronchoscopes are only compatible with Nd: YAG laser or 810 nm diode lasers in laser therapy treatment. Again, rather than recalling the device and removing it from use, they urged users to reread the Olympus Operation Manuals that warn users not to perform laser cauterization while supplying oxygen.
What to Do If You Are Injured by a Defective Medical Device?
Injuries caused by defective medical devices can fall under two distinct areas of law: medical product liability or medical malpractice. Both of these areas of law are complex, highly regulated, and often highly specialized areas of practice. If you have questions about an injury you suspect may be due to a defective medical product, talk to a Houston product liability lawyer about your rights. The law firm of Simmons and Fletcher, P.C., Injury & Accident Lawyers has fighting for injured victims’ rights since 1979. Consultations are free and no obligation. When we take on a case or you sign on with one of our co-counsel law firms, we ensure that you pay no attorney fees and no attorney expenses unless a recovery is made on your behalf.
You can also learn about these and other FDA recalls here.
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