Recall Z-0194-2024 ยท EOQ Bronchoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
| 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 | 3948 devices |
| Distribution | US Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201758 | EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 Olympus Medical Systems Corp., Jan 21, 2021 |