Recall Z-0192-2024 ยท NWB Endoscope, Accessories, Narrow Band Spectrum
Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
| Date | Nov 9, 2023 (initiated Oct 12, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | An "URGENT MEDICAL DEVICE CORRECTIVE ACTION" notification letter dated 10/12/23 was sent to customers. Actions to be taken by the end user: Our records indicate that your facility has purchased one or more of the affected bronchoscopes. Olympus requests you to take the following actions: 1. Inspect your facility for the referenced devices and ensure all personnel are completely knowledgeable and thoroughly aware of the Warnings in affected bronchoscope s Operation Manual for use with High-frequency therapy equipment and that Olympus high-frequency compatible bronchoscopes are compatible only |
| Quantity | 32211 devices |
| Distribution | US Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121959 | EVIS EXERA III VIDEO SYSTEM Olympus Medical Systems Corp., Jan 10, 2013 |