Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-07-27 | Z-2495-2023 | Class II | Open, Classified | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.Distribution: US Nationwide distribution. | 1859 units | code info di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2022-12-12 | WL | Warning Letter | Olympus Medical Systems Corporation | — |
| 2022-09-09 | OAI | Official action indicated | Olympus Medical Systems Corporation | 1 |
| 2018-03-09 | WL | Warning Letter | Olympus Medical Systems Corporation | — |
| 2015-04-24 | OAI | Official action indicated | Olympus Medical Systems Corporation | 2 |
Similar devices
- Monarch Endoscopy Platform (P1) Tower Upgrade Auris Health, Inc.
- Monarch Endoscopy Platform (P1) Tower Upgrade Auris Health, Inc.
- Single-use Broncho Videoscope Scivita Medical Technology Co., Ltd.
- Single-use Broncho Videoscope Scivita Medical Technology Co., Ltd.
- Accessory Kit Noah Medical Corporation
- Acquire™ Pulmonary BOSTON SCIENTIFIC CORPORATION
- Acquire™ Pulmonary BOSTON SCIENTIFIC CORPORATION
- Adult Base EFER ENDOSCOPY
- Adult bronchial tube EFER ENDOSCOPY
- Adult bronchial tube EFER ENDOSCOPY
- Adult bronchial tube EFER ENDOSCOPY
- Adult bronchial tube EFER ENDOSCOPY
Select up to two to place side-by-side with this device.