Recall Z-2014-2023 ยท EOQ Bronchoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
| Date | Jul 17, 2023 (initiated Jun 8, 2023) |
| Status | Open, Classified |
| Reason | There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. |
| Root cause | Under Investigation by firm |
| Action | An "URGENT MEDICAL DEVICE CORRECTIVE ACTION" notification letter dated 6/8/23 was sent to customers. Actions to be taken by the company: The labelling will be updated to include specificity about laser compatibility, improved instructions regarding patient preparation, and warnings about patient injury and death resulting from incompatible laser use. Actions to be taken by the end user: 1. Inspect your inventory for the referenced devices and identify any device with the model names. Please check all areas of the hospital to determine if any of these devices remain in inventory. 2. Carefully |
| Quantity | 284 units |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023984 | MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES The Olympus Optical Co., Jan 31, 2003 |