Olympus Corp has introduced a voluntary discipline corrective motion to handle complaints of endobronchial combustion occurring throughout therapeutic procedures involving use of high-frequency remedy gear in an oxygenated atmosphere.
Olympus assessed the problem after receiving complaints of opposed occasions involving severe affected person harm, the place sufferers might undergo burns to the airway or lungs that will outcome within the want for added medical intervention, extended process instances, prolonged hospitalization, ICU care, and dying.
Olympus took motion to inform customers about these complaints and reinforce current warnings to be used of bronchoscopes with high-frequency remedy gear. This isn’t a removing motion. Olympus bronchoscopes appropriate to be used with specified high-frequency remedy gear can proceed for use following the directions and warnings contained within the Olympus Operation Guide.
Olympus bronchoscopes are meant to be used in endoscopic analysis and therapy inside the airways and the tracheobronchial tree. A complete of 28 BF collection endoscope fashions are globally included on this motion. Fifteen of these fashions had been distributed within the US. The US Meals and Drug Administration (FDA) and different regulatory our bodies had been notified of this motion, in line with a launch kind Olympus.
Olympus notified prospects within the US by letter on Oct 12, requesting that well being care personnel treating sufferers utilizing an Olympus bronchofiberscope or bronchovideoscope rigorously learn the complete Medical System Corrective Motion and guarantee all personnel are fully educated and completely conscious of the warnings to be used with appropriate high-frequency remedy gear, reminiscent of electrosurgical mills.
Olympus is reminding customers to pay cautious consideration to warnings within the Operation Guide on high-frequency cauterization with Olympus bronchoscopes. Olympus Operation Manuals warn to not carry out high-frequency cauterization whereas supplying oxygen. This will end in combustion throughout cauterization.
As well as, to keep away from affected person harm (burns, bleeding, and perforation) or injury to the machine, affirm the electrode part of the electrosurgical accent is at an acceptable distance from the endoscope’s distal finish. Customers might proceed to make use of the machine in line with the prevailing directions and warnings contained within the Operation Guide.
This can be a separate discipline corrective motion from one issued earlier this 12 months concerning bronchoscope use with laser remedy gear.
Opposed reactions or high quality issues skilled with using these merchandise could also be reported to the FDA’s MedWatch program on-line.
For info or to report an issue, contact the Olympus Technical Help Middle at 800-848-9024, Choice 1, or electronic mail [email protected].
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