Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Olympus Medical Systems Corp., has issued a medical device safety alert concerning its bronchoscopes [Model: BF-1T150, BF-1T180, BF-1T260, BF-1T60, BF-1TH1100, BF-1TH1200, BF-1TH190, BF-1TQ170, BF-1TQ180, BF-1TQ290, BF-260, BF-6C260, BF-F260, BF-H1100, BF-H1200, BF-H190, BF-H290, BF-P150, BF-P180, BF-P190, BF-P290, BF-P60, BF-Q170, BF-Q180-AC, BF-Q190, BF-Q290, BF-XT160, BF-XT190]. [HKMD No.: 140190, 140191, 230034].
The manufacturer has received four adverse event complaints of endobronchial combustion during therapeutic procedures with the Olympus bronchoscope model BF-XT190, of which one involved high-frequency therapy equipment. The other three adverse events involved unknown energy therapy equipment.
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. If endobronchial combustion occurs, patients may suffer critical internal burns to the airway or lungs that may result in a requirement for additional medical intervention, prolonged procedure, extended hospitalization or ICU care, and death. Combustion can also result in damage to or breakage of device components that may injure or remain unintendedly in the patient and/or may require retrieval or surgical removal.
The manufacturer is reminding users of warnings within Olympus bronchoscope Operation Manuals for use of the subject bronchoscopes with high-frequency equipment.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 Oct 2023