Olympus Company of the Americas (Olympus) is recalling sure bronchofiberscopes and bronchovideoscopes as a result of they might result in burns or catch hearth, in keeping with a security communication from the US Meals and Drug Administration (FDA).
The FDA has recognized this as a category I recall, probably the most severe sort of recall.
Utilizing the affected bronchoscopes might trigger severe antagonistic well being penalties, together with vital burns in an individual’s airways or lungs, airway bleeding, bother respiration, apnea, lack of consciousness, or demise. Accidents might result in extended procedures, extra medical care, prolonged hospitalization, ICU care, and demise. Combustion can injury or break components of the machine which will injure or unintentionally stay within the affected person and should require retrieval or surgical removing.
There have been 192 complaints relating to this subject, together with 4 accidents. There have been no deaths reported.
There’s a danger of combustion if:
- high-frequency cauterization is carried out whereas supplying oxygen, or
- the electrode part of an electrosurgical accent is simply too near the tip of the endoscope.
On Oct 12, Olympus despatched all affected clients an pressing medical machine corrective motion. The letter requested clients to evaluation the warning part within the machine’s operations handbook, particularly:
- Cease performing high-frequency cauterization whereas supplying oxygen.
- Preserve electrosurgical units used with the endoscope far sufficient away from the endoscope.
- Solely use high-frequency gear that’s appropriate with the Olympus bronchoscope, as listed within the operations handbook.
Full Checklist of Affected Gadgets
|Bronchovideoscope Olympus BF Kind 1T150
|Evis Exera II Bronchovideoscope Olympus BF Kind 1T180
|OES Bronchofiberscope Olympus BF Kind 1T60
|Evis Exera III Bronchovideoscope Olympus BF-1TH190
|Evis Exera II Bronchovideoscope Olympus BF Kind 1TQ180
|Evis Exera III Bronchovideoscope Olympus BF-H190
|Bronchovideoscope Olympus BF Kind P150
|Evis Exera II Bronchovideoscope Olympus BF Kind P180
|Evis Exera III Bronchovideoscope Olympus BF-P190
|OES Bronchofiberscope Olympus BF Kind P60
|Bronchovideoscope Olympus BF-Q170
|Evis Exera II Bronchovideoscope Olympus BF Kind Q180-AC
|Evis Exera III Bronchovideoscope Olympus BF-Q190
|Evis Exera Bronchovideoscope Olympus BF Kind XT160
|Evis Exera III Bronchovideoscope Olympus BF-XT190
Well being care professionals and shoppers might report antagonistic reactions or high quality issues they skilled utilizing these units to MedWatch: The FDA Security Info and Hostile Occasion Reporting Program utilizing a web-based kind, common mail, or FAX.