Olympus is warning health providers about incompatible laser use with bronchoscopes after receiving reports of endobronchial combustion, serious patient injury, and one death.
The Japanese medtech giant said on July 3 that its voluntary field corrective action involves 32 BF series endoscope models, 19 of which it distributes in the U.S. The company has notified the FDA and other regulatory bodies globally of the action.
Olympus is not removing the devices from the market. Rather, it is updated labeling. The company is requesting that healthcare personnel carefully read the full Medical Device Corrective Action and addendum detailing compatible laser types.
Said the company: “Patient and healthcare provider safety, and mitigating any potential risks are our top priorities.”
According to Olympus, its laser-compatible bronchoscopes are compatible only with Nd: YAG laser or 810 nm diode lasers. The company has not evaluated any other lasers for compatibility with the indicated bronchoscope models.
Olympus says it notified customers in a June 8 letter.
The company, in its July 3 news release, had additional warnings:
“Additionally, Olympus is reminding users to pay careful attention to warnings in the operation manual on laser cauterization with Olympus bronchoscopes Olympus operation manuals warn not to perform laser cauterization while supplying oxygen. This may result in combustion during cauterization. In addition, to avoid patient injury (burns, bleeding, and perforation) or damage to the device, never emit laser radiation from an approved laser before confirming that an appropriate distance between the target and endoscope’s distal end with the tip of the laser probe is in the correct position in the endoscopic image.”
Although Olympus received one complaint of endobronchial combustion with argon plasma coagulation, the cause of the combustion event could not be determined. The company is not making labeling updates to the use of APC.
